ORC
6 FDA 510(k) clearances · Product code
293 daysmedian time to decision
616 days90th percentile
6clearances measured
FDA profile
- Official device name
- Air Filter Portable Apparatus
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.5070
- Medical specialty
- General, Plastic Surgery
- Flags
- Third-party review eligible
- FDA definition
- The sytem is intended to control the surgical environment to prevent bacterial contamination during surgical procedures.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| SteriStay (K190027) | Toul Meditech AB | 2019-05-10 |
| Operio (K173349) | Toul Meditech AB | 2017-12-20 |
| SurgiCube (K163455) | Surgicube International B.V. | 2017-09-28 |
| Operio (K153498) | Toul Meditech AB | 2016-07-20 |
| AIR BARRIER SYSTEM (ABS) (K123006) | Nimbic Systems, Inc. | 2013-12-20 |
| ABS BLOWER, ABS NOZZLE, MODEL 1001 (K092801) | Nimbic Systems, LLC | 2011-05-20 |
Track ORC automatically
Every clearance here is in the API, with alerts when new ones post.