ORC · Air Filter Portable Apparatus
General, Plastic Surgery · 21 CFR 878.5070 · Class 2
Overview
| Product Code | ORC |
|---|---|
| Device Name | Air Filter Portable Apparatus |
| Regulation | 21 CFR 878.5070 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
| 3rd-Party Reviewable | Yes |
Identification
Air-handling apparatus for a surgical operating room is a device intended to produce a directed, nonturbulent flow of air that has been filtered to remove particulate matter and microorganisms to provide an area free of contaminants to reduce the possibility of infection in the patient.
Classification Rationale
Class II (special controls). The device, when it is an air handling bench apparatus, an air handling room apparatus, or an air handling enclosure apparatus, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.
Special Controls
*Classification.* Class II (special controls). The device, when it is an air handling bench apparatus, an air handling room apparatus, or an air handling enclosure apparatus, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.
Recent Cleared Devices (6 of 6)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K190027 | SteriStay | Toul Meditech AB | May 10, 2019 | SESE |
| K173349 | Operio | Toul Meditech AB | Dec 20, 2017 | SESE |
| K163455 | SurgiCube | Surgicube International B.V. | Sep 28, 2017 | SESE |
| K153498 | Operio | Toul Meditech AB | Jul 20, 2016 | SESE |
| K123006 | AIR BARRIER SYSTEM (ABS) | Nimbic Systems, Inc. | Dec 20, 2013 | SESE |
| K092801 | ABS BLOWER, ABS NOZZLE, MODEL 1001 | Nimbic Systems, LLC | May 20, 2011 | SESE |
Top Applicants
- Toul Meditech AB — 3 clearances
- Nimbic Systems, Inc. — 1 clearance
- Nimbic Systems, LLC — 1 clearance
- Surgicube International B.V. — 1 clearance
