# K142138: Iso-Gard Mask

- Pathway: 510(k) (Traditional)
- Applicant: Teleflexmedical, Inc.
- Decided: Oct 30, 2014 after 86 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: 4 generations back to K863883 (1986). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132729: Iso-Gard Mask, Teleflexmedical, Inc. (2014) Summary page 4.

## Indications for use
The ISO-Gard® 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® Mask helps to reduce the amount of anesthetic agents released to the work environment of the healthcare worker.

Source page: https://510kreport.com/device/K142138
Methodology: https://510kreport.com/methodology