FDA 510(k) microbiology devices include diagnostic systems used to detect and identify bacteria, viruses, fungi and parasites. The FDA review panel code is MI.
Key device types:
| Period | Avg days (cleared) |
|---|---|
| Last 2 years | 159d |
| All-time average (cleared) | 102d |
| Not Substantially Equivalent (denied) | 275d |
Recent Microbiology submissions have taken longer than the historical average - 159 days in the last 2 years vs 102 days historically. Factor this into your 510(k) submission timeline planning. Denied submissions averaged 275 days before receiving a Not Substantially Equivalent determination.
This page lists all 7048 medical devices in the Microbiology specialty that have been submitted to the FDA through the 510(k) premarket notification process. Culture systems, microbial identification and infectious disease test kits.
This page lists 7048 medical devices in the Microbiology specialty submitted to the FDA through the 510(k) premarket notification process. Of these, 6986 were cleared as substantially equivalent to a predicate device. Average FDA review time: 102 days. Records from 1976 to the present.
You can use this list to:
Each entry includes: device name, 510(k) number, product code, manufacturer and FDA decision date. Click any device to view the full submission details.
This information is based on publicly available FDA data and is intended for informational purposes only. It may not reflect current market or regulatory status. Always verify critical information at accessdata.fda.gov.
Looking for a specific microbiology device? Search by device name, K-number or manufacturer.
Search all Microbiology 510(k) devices