# K020785: Introcan Safety IV Catheter

- Pathway: 510(k) (Traditional)
- Applicant: B.Braun Medical, Inc.
- Decided: Aug 28, 2002 after 170 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: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K801941 (1980). 4 ancestors in all.
55 later devices descend from it; 8 cite it directly.
0 of 60 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982805: Introcan Safety IV Catheter, B.Braun Medical, Inc. (1999) Summary page 1.
- K990236: Modification of Jelco*,Jelco*-W and Jelco* Plus I.V. Catheters, Cathlon* I.V. Catheters, Optiva* I.V. Catheters, Protect, Johnson & Johnson Medical, Div. of Ethicon, Inc. (1999) Summary page 1.
- K971339: Insyte, Insyte-W, Insyte Autoguard Catheters, Becton Dickinson Vascular Access, Inc. (1997) Summary page 1.

## Most influential descendants
- 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
- K133856: Powerglide Midline Catheter (2014), 12 descendants of its own
- K163358: Introcan Safety 3 Closed IV Catheter (2017), 9 descendants of its own

## Recalls of this device
- Sep 1, 2022 · Class II · Z-0009-2023: Potential for leakage at the catheter hub.
- 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 devices for venous or arterial access for the infusion of fluids, drugs, and/or blood components. 14 - 22 gauge catheters may be used with power injectors for which the maximum pressure setting is 300 psi.

Source page: https://510kreport.com/device/K020785
Methodology: https://510kreport.com/methodology