2019 US 510(k) Clearances Analysis and FDA’s target to receive innovative technologies first in 2020

26 February 2020 |

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We have recently been covering several new initiatives at the United States FDA CDRH, and as such thought it would be fitting to provide a round-up for the 510(k) activities in 2019. In this article, we explore some of the 2019 trends in 510(k) clearances and what these may be saying about the evolving industry.


Our recent coverage included a webinar on the 510(k) Modernisation Initiatives (see webinar).

In addition, we recently hosted the FDA discussing one of their latest initiatives: the Case for Quality (see webinar) which was kicked-off by the FDA with a comprehensive report issued in October 2011 titled “Understanding Barriers to Medical Device Quality” (see report here). The 2011 report provides great insight into trends for medical devices in the US.

The report concluded that the enforcement activities were not adequately aligning industry activity with the objective of improving the quality of medical devices. Furthermore, it recommended a new collaborative approach to reduce the historical “wack-a-mole” (a term used directly by the FDA to suggest a reactionary method of enforcement), which emphasises compliance over improvement.

At our consultancy, we always say information is power, this report outlines some insights that may be valuable for those planning for and desiring insights regarding 510(k) clearances.

Below are some interesting figures from the 2011 report:

The report indicated that Medical Devices sales in the US had been growing by 9% per year while the number of 510(k) clearances were declining by 2% per year. Which could mean that the players in the market are growing their sales without necessarily commercialising new technologies.

Interestingly, when the number of serious adverse events was normalised by revenue, there was a surprising trend that adverse events over revenue was growing at 14% in recent years. This trend could possibly mean that higher revenues in the field were not being translated into product improvements or safer products.

Overall the 2011 Report from FDA highlighted the following needs to:

  1. Align compliance focus to address industry quality needs.
  2. Enhance transparency and visibility of Agency data to drive quality.
  3. Increase industry engagement.

It concluded that “Investment by FDA now in a holistic quality infrastructure will support a next generation of medical devices that are as safe and well-made as they are innovative.”

More recently, in FDA’s 2018-2020 Strategic Priorities Report published in January 2018 (link here) the FDA outlined that one of its top measures of success would be that:

“By 31 December 2020, more than 50% of manufactures of novel technologies for the U.S. Markets intend to bring their devices to the U.S. first or in parallel with other major markets”

In the 2018-2020 report, the FDA designated novel technologies as PMA, Panel track supplements, De Novo, Humanitarian Device Exemptions or a Premarket notification 510(k) under the Breakthrough Devices Program.

This metric aims to sum up the effect of the Strategic Priorities that FDA has set out to make the US regulatory framework more attractive for medical device innovators. This target of increasing those considering launching in the US in the first wave to 50%, would be a significant increase from a baseline of 4% who planned to launch in US in their first wave back in 2011, according to a Northwestern University Study which found that 80% of devices were being launched first in Europe (link here), a trend that is naturally going to be aided by the recent MDR/IVDR challenges transpiring in Europe.

2019 510(k) Clearances Analysis

Since Class II devices are governed by the 510(k) clearance program in the US and these represent approximately 80% of the work-load from the FDA; we focus on 510(k)s in this analysis to get a pulse on the industry.

The analysis comes from the 510(k) Clearances Releasable Databases (FDA site link here). We will review address the following questions:

  • Are more 510(k)s being approved and are they taking longer?
  • What countries did most of the 510(k) applications come from in 2019?
  • What were the top product codes receiving 510(k) clearances in 2019?

Are more 510(k)s being approved and are they taking longer?

As the below analysis shows, the number of approvals has remained at about the same number per year. To disprove the possibility that there has been a change in the number of applications, we reviewed the number of applications submitted per year, and indeed the number of applications has remained relatively stable, at about 3,000 per year.

The number of days from submission to an FDA decision has fluctuated between 160 and 145 days since 2013. Further, since 2013 there hasn’t been a significant change in the number of days between receipt of the 510(k) application and decision.

What countries did most of the 510(k) applications come from in 2019?

Consistent with historical levels in 2019, the vast majority of 510(k)s list their filing address from the US, namely 58%. The rest of the top 20 countries comprise 97% of total 510(k) reviewed in 2019. The breakdown of 510(k)s by country signifies a good pulse for the amount of medical device innovation happening in each country and the volume of medical technologies being developed and marketed in each.

What were the top product codes receiving 510(k) clearances in 2019?

The chart below outlines the top 510(k) cleared product codes issued in 2019. At the top of the list was “System, Image Processing, Radiological” which falls in line with the trend of increased number of software based medical devices.

The overall the distribution of product codes for 510(k)s remains very diversified over 731 total 510(k) product codes applied for in 2019.


The FDA’s ambitious targets to simplify and achieve more predictability in medical device regulation is a great objective. Coupled with smarter enforcement expected to be realised from programs like the Case for Quality and the Pre-Cert Program, the goal should be achievable. The time seems ideal considering the challenges that MDR/IVDR implementations and the shortage of accredited notified bodies are slated to cause in Europe is likely to make medical innovators rethink their go to market strategy.

As for 2019, the time for approval and number of applications for 510(k) in the US seems to remain levelled. The top 20 of countries account for 98% of the total number of 510(k) applications submitted in 2019. Further, the number of 510(k) issued is growing in number for diagnostic and software-based products, a trend that is expected to continue and increase.

Time will tell if the FDA strategic objectives will be achieved, however we see all these efforts as great strides in the right direction.

If you have questions about how to navigate the use of standards and managing test programs, please reach out. We have a staff of consultants with extensive expertise. Whether it’s a TGA application, a strategy for MDR transition, a US presubmission or 510(k) filing, or specific help with regulatory documents (e.g. Clinical Evaluation Reports), or an update of your quality system to gain MDSAP. We understand you need a commercial approach which delivers viable options. Contact us to discuss your needs and how we can help. You can drop us an email [email protected] or call 1 888-271-5063 (US toll free) ♦ +61 2 9906 2984 (Sydney)

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