# K962182: Burlew Infant Hood

- Pathway: 510(k) (Traditional)
- Applicant: Promedic, Inc.
- Decided: Jul 15, 1996 after 39 days
- Product code: FOG (Hood, Oxygen, Infant)
- Device class: 1
- Regulation: 21 CFR 868.5700
- 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 K893713 (1989). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K893713: Nova Oxygen Tent, Nova Health Systems, Inc. (1989) Summary page 1.
- (no number) Sunnydale: named in the summary without a submission number
- (no number) Utah Medical - Disposa-Hood: named in the summary without a submission number

## Indications for use
The device indicated for patients who need to be placed in an oxygen enriched environment.

Source page: https://510kreport.com/device/K962182
Methodology: https://510kreport.com/methodology