# K123006: Air Barrier System (Abs)

- Pathway: 510(k) (Traditional)
- Applicant: Nimbic Systems, Inc.
- Decided: Dec 20, 2013 after 449 days
- Product code: ORC (Air Filter Portable Apparatus)
- Device class: 2
- Regulation: 21 CFR 878.5070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K831531 (1984). 2 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092801: Abs Blower, Abs Nozzle, Model 1001, Nimbic Systems, LLC (2011) Summary page 1.

## Most influential descendants
- K153498: Operio (2016), 2 descendants of its own
- K173349: Operio (2017), 0 descendants of its own
- K163455: SurgiCube (2017), 0 descendants of its own

## Indications for use
The Air Barrier System is a portable device for use in a surgical operating room that produces a directed, non-turbulent flow of air to the surgical site. The air flow from the device is HEPA-filtered to reduce the presence of particulate matter and microorganisms at the surgical site during hip arthroplasty and posterior vertebral fusion and laminoplasty. The ABS Nozzle is intended to be used only where: (1) it can be placed on an anatomical surface with no gap between the bottom of the nozzle and the surface, (2) the incision plane is parallel with the direction of air flow, and (3) the incision dimensions are within: 6" (15.2 cm) in width and 20" (50.8 cm) in length. Device effectiveness may not be reliably detectable at a distance of 20 inches from the Nozzle, and effectiveness depreciates beyond this specified area.

Source page: https://510kreport.com/device/K123006
Methodology: https://510kreport.com/methodology