FDA product code ORC: Air Filter Portable Apparatus
ORC is the FDA product code for air filter portable apparatus. It is a Class II device, regulated under 21 CFR 878.5070 and reviewed by the General Hospital panel. FDA has cleared 6 510(k) submissions under ORC, from 4 different applicants. The average 510(k) review took 294 days (median 260).
Definition
The sytem is intended to control the surgical environment to prevent bacterial contamination during surgical procedures.
Classification
| Field | Value |
|---|---|
| Device name | Air Filter Portable Apparatus |
| Device class | Class II |
| Regulation | 21 CFR 878.5070 |
| Review panel | HO — General Hospital |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for ORC
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 174 |
| 2019 | 1 | 123 |
Compare with all 510(k) review times · Search every ORC clearance
Top ORC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Toul Meditech AB | 3 | 2019-05-10 |
| Surgicube International B.V. | 1 | 2017-09-28 |
| Nimbic Systems, Inc. | 1 | 2013-12-20 |
| Nimbic Systems, LLC | 1 | 2011-05-20 |
Most recent ORC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K190027 | Toul Meditech AB | SteriStay | 2019-05-10 | 123 |
| K173349 | Toul Meditech AB | Operio | 2017-12-20 | 56 |
| K163455 | Surgicube International B.V. | SurgiCube | 2017-09-28 | 293 |
| K153498 | Toul Meditech AB | Operio | 2016-07-20 | 226 |
| K123006 | Nimbic Systems, Inc. | AIR BARRIER SYSTEM (ABS) | 2013-12-20 | 449 |
Recalls for ORC devices
openFDA lists no recalls for product code ORC.
Frequently asked questions
What is FDA product code ORC?
ORC is the FDA product code for air filter portable apparatus. It is a Class II device, regulated under 21 CFR 878.5070 and reviewed by the General Hospital panel.
What device class is ORC?
Class II, regulation 21 CFR 878.5070. Typical premarket route: 510(k).
How long does a 510(k) take for product code ORC?
Across 6 cleared submissions the average was 294 days from receipt to decision (median 260).
Which companies have the most ORC clearances?
Toul Meditech AB (3); Surgicube International B.V. (1); Nimbic Systems, Inc. (1); Nimbic Systems, LLC (1).
Next steps
- Run an FDA pathway report with predicate devices for product code ORC
- Run a recall and safety report across every ORC manufacturer
- Watch product code ORC for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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