How long it has historically taken the FDA to clear 510(k) submissions

Emergo conducted a review of public data on medical devices cleared by the US Food and Drug Administration between January 1, 2011 and December 31, 2015. The 15,000+ device clearances examined went through the FDA’s Premarket Notification program, more commonly known as the 510(k). This process applies to nearly all Class 2 devices, and a small percentage of Class 1 and 3 devices.

Want to know the historical average review time for your device? Be sure to try our popualr FDA 510(k) calculator, which shows the average review time for specific devices cleared by FDA. Try the calculator now.

NOTE: The FDA does not release data on how many 510(k) submissions are rejected outright, withdrawn or abandoned by the submitter. This analysis only includes devices cleared by the FDA and does not include devices subject to the Pre Market Approval (PMA) process.

US FDA 510(k) review time analysis

510(k) review times have been flat in recent years, but over time have steadily grown...

Average calendar days from submission to clearance for Traditional 510(k)

In 2015, the majority of devices were cleared within 9 months...

Percent of Traditional 510(k) submissions cleared by internal FDA reviewers

Fewer devices were cleared in 2015, especially from US companies...

All FDA 510(k) submissions cleared: Traditional, Special, Abbreviated

Review times vary widely by device category...

Average calendar days from submission to clearance for Traditional 5110(k)

Using a Third Party Review will shave an average of 100 days off the process...but at a cost

Average calendar days from submission to clearance for Traditional 510(k) (all reviewers)

Special and Abbreviated 510(k)

Average calendar days from submission to clearance for Special 510(k)

Average calendar days from submission to clearance for Abbreviated 510(k)

NOTE: Only 5% of devices are cleared via Abbreviated 510(k) submissions. According to the FDA: "Device manufacturers may choose to submit an Abbreviated 510(k) when a guidance document exists, a special control has been established, or the FDA has recognized a relevant consensus standard. An Abbreviated 510(k) submission must include the required elements identified in a Traditional 510(k). However, in an Abbreviated 510(k) submission, firms elect to provide summary reports on the use of guidance documents and/or special controls or declarations of conformity to FDA recognized standards to expedite the review of a submission."

Little known facts about the FDA 510(k)

  • The FDA has cleared more than 140,000 devices via the 510(k) program since its inception in 1976
  • Back when the 510(k) program started, the average time to get a device cleared was just 38 days.
  • The longest time ever to get 510(k) clearance was for three submissions filed by the same company at the same time in late 1998. Those devices cleared in early 2007 – a whopping 3,037 days (8.3 years) later!

All 510(k) submissions are assigned a “K number” – the letter K followed by six digits. The first two digits of the 510(k) number indicate the year it was submitted to FDA for review. The next four digits are sequential starting at 0 and indicate the order in which the submission was received during the year. The first 510(k) ever was submitted by Zimmer Inc. which holds K760001, submitted on May 26, 1976. Boston Scientific Scimed Inc. is the proud owner of K000001. No, it's not the first 510(k) ever, but it was the first one submitted in the new millennium on January 3, 2000! Many others were submitted that same day but their submission made it to the top of the pile!

We hope you find this information to be useful and I welcome your feedback:

Chris Schorre
Vice President of Global Marketing
Austin, Texas USA
+1 512 600 7606