# K092801: Abs Blower, Abs Nozzle, Model 1001

- Pathway: 510(k) (Traditional)
- Applicant: Nimbic Systems, LLC
- Decided: May 20, 2011 after 616 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: 1 generation back to K831531 (1984). 1 ancestor in all.
4 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)
- K831531: Surgical Isolation Barrier System, Lone Star Medical Products, Inc. (1984) Summary page 1.

## Most influential descendants
- K123006: Air Barrier System (Abs) (2013), 3 descendants of its own
- 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. 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 to the direction of airflow, 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/K092801
Methodology: https://510kreport.com/methodology