Air Filter Portable Apparatus
The Air Filter Portable Apparatus (product code ORC) is a surgical environment control system intended to prevent bacterial contamination during surgical procedures by filtering the air in the operative field. It is a portable unit that can be deployed in operating rooms to reduce the risk of surgical site infections. As an FDA Class 2 device under regulation 878.5070, it requires 510(k) premarket clearance and falls within the General and Plastic Surgery specialty, reviewed by the General Hospital panel. The device is eligible for third-party review and is not an implant or life-sustaining device.
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Basic Information
- Product Code
- ORC
- Device Class
- FDA class 2
- Regulation Number
- 878.5070
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- HO
- Submission Type
- 1
Device Characteristics
Definition
The sytem is intended to control the surgical environment to prevent bacterial contamination during surgical procedures.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K190027 | SteriStay | May 10, 2019 | Substantially Equivalent | Toul Meditech AB |
| K173349 | Operio | Dec 20, 2017 | Substantially Equivalent | Toul Meditech AB |
| K163455 | SurgiCube | Sep 28, 2017 | Substantially Equivalent | Surgicube International B.V. |
| K153498 | Operio | Jul 20, 2016 | Substantially Equivalent | Toul Meditech AB |
| K123006 | AIR BARRIER SYSTEM (ABS) | Dec 20, 2013 | Substantially Equivalent | Nimbic Systems, Inc. |
| K092801 | ABS BLOWER, ABS NOZZLE, MODEL 1001 | May 20, 2011 | Substantially Equivalent | Nimbic Systems, LLC |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.