# K962161: Baxter Nebulizer Cap Model 2D0868

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: Aug 15, 1996 after 72 days
- Product code: CAF (Nebulizer (Direct Patient Interface))
- Device class: 2
- Regulation: 21 CFR 868.5630
- 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 K780406 (1978). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K780406: 2C7153 Nebulizer Cap, Travenol Laboratories, S.A. (1978) Summary page 1.

## Most influential descendants
- K072119: Airlife Nebulizer Cap (2007), 0 descendants of its own

## Indications for use
The Baxter Healthcare Corporation’s Nebulizer Cap is for use with Sterile Water for Inhalation, USP, in 500 ml, 1000 ml, and 1500 ml plastic bottles, for inhalation therapy only.

Source page: https://510kreport.com/device/K962161
Methodology: https://510kreport.com/methodology