PEX
5 FDA 510(k) clearances · Product code
231 daysmedian time to decision
271 days90th percentile
5clearances measured
FDA profile
- Official device name
- System, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3361
- Medical specialty
- Microbiology
- FDA definition
- A mass spectrometer system using matrix-assisted laser desorption/ ionization - time of flight (MALDI-TOF) for the identification of microorganisms cultured from human specimens.
- Adverse events (MAUDE)
- 2015: 23 · 2016: 48 · 2017: 94 · 2018: 66 · 2019: 107 · 2020: 89
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| MALDI Biotyper CA (MBT-CA) System, MBT smart CA System (K163536) | Bruker Daltonik GmbH | 2017-07-26 |
| VITEK MS (K162950) | bioMerieux, Inc. | 2017-07-22 |
| MALDI Biotyper CA System (K142677) | Bruker Daltonics, Inc. | 2015-03-27 |
| MALDI BIOTYPER CA (MBT-CA) SYSTEM (K130831) | Bruker Daltonics, Inc. | 2013-11-21 |
| VITEK MS (DEN130013) | bioMerieux, Inc. | 2013-08-21 |
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Every clearance here is in the API, with alerts when new ones post.