# K123176: Iso-Gard Clearair Mask

- Pathway: 510(k) (Traditional)
- Applicant: Teleflexmedical, Inc.
- Decided: Feb 14, 2013 after 127 days
- Product code: CBN (Apparatus, Gas-Scavenging)
- Device class: 2
- Regulation: 21 CFR 868.5430
- 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 K863883 (1986). 5 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953269: Safecircuit Manifold/Pulmonary Unit, Advanced Warming Systems, Inc. (1996) Summary page 1.
- K950771: Disposable Adhesive Face Mask, Advanced Warming Systems, Inc. (1995) Summary page 1.
- K961150: Dual Lumen Oxygen Delivery Gas Sampling Cannula, Hudson Respiratory Care, Inc. (1996) Summary page 1.

## Most influential descendants
- K132729: Iso-Gard Mask (2014), 1 descendant of its own
- K142138: Iso-Gard Mask (2014), 0 descendants of its own

## Indications for use
The ISO-GARD® ClearAirTm Mask is intended to be used to scavenge waste anesthetic gases from patients during recovery from general anesthesia and to provide supplemental oxygen. The ISO-GARD® ClearAirTm Mask helps to reduce the amount of anesthetic agents released to the work environment ofthe healthcare worker.

Source page: https://510kreport.com/device/K123176
Methodology: https://510kreport.com/methodology