# K946170: Comfort-Q Subcutaneous Injection Sets

- Pathway: 510(k) (Traditional)
- Applicant: B. Braun of America, Inc.
- Decided: Nov 3, 1995 after 319 days
- Product code: FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days)
- Device class: 2
- Regulation: 21 CFR 880.5200
- 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 K801941 (1980). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K801941: Burron Microcath Intra. Cath. Placementt, Burron Medical Products, Inc. (1980)
- K873885: Pharmacia Deltec Subcutaneous Infusion Set, Pharmacia Deltec, Inc. (1987)

## Indications for use
The intended use for administration of fluids or other therapeutic agents subcutaneously.

Source page: https://510kreport.com/device/K946170
Methodology: https://510kreport.com/methodology