# K982805: Introcan Safety IV Catheter

- Pathway: 510(k) (Traditional)
- Applicant: B.Braun Medical, Inc.
- Decided: Jan 14, 1999 after 157 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K801941 (1980). 1 ancestor in all.
70 later devices descend from it; 5 cite it directly.
0 of 72 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) Summary page 1.

## Most influential descendants
- K020785: Introcan Safety IV Catheter (2002), 55 descendants of its own
- K021094: Introcan Safety IV Catheter (2002), 26 descendants of its own
- K101422: The Power Wand Safety Introducer with an Extended Dwell Catheter (2011), 25 descendants of its own
- K121073: Powerglide Midline Catheter (2012), 19 descendants of its own
- K111236: Introcan Safety (R) 3 Closed IV Catheter 18GA X 1-3/4 (45MM) and 18GA X 1-1/4 (32MM) / 20GA X 1-1/4 (32MM) / 20GA X 1 (2011), 15 descendants of its own

## Recalls of this device
- Mar 19, 2004 · Not classified · Z-1092-04: Mislabeled product. The recalling firm received a complaint that a box of Introcan Safety Catheters, (22G x 1 inch) contained mixed 18G catheters with the same lot number.

## Indications for use
Passive anti-needle stick device to be placed in a peripheral vein for the infusion of fluids, drugs and/or blood components.

Source page: https://510kreport.com/device/K982805
Methodology: https://510kreport.com/methodology