# K990236: Modification of Jelco*,Jelco*-W and Jelco* Plus I.V. Catheters, Cathlon* I.V. Catheters, Optiva* I.V. Catheters, Protect

- Pathway: 510(k) (Traditional)
- Applicant: Johnson & Johnson Medical, Div. of Ethicon, Inc.
- Decided: Aug 20, 1999 after 207 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
No predicates in its family tree.
58 later devices descend from it; 2 cite it directly.
0 of 59 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) JELCO, JELCO-W, and JELCO PLUS I.V. Catheters: named in the summary without a submission number
- (no number) CATHLON I.V. Catheters: named in the summary without a submission number
- (no number) OPTIVA I.V. Catheters: named in the summary without a submission number
- (no number) PROTECTIV, PROTECTIV-W, PROTECTIV PLUS, and PROTECTIV PLUS-W I.V. Catheter Safety Systems: named in the summary without a submission number
- (no number) Becton-Dickinson INSYTE, INSYTE-W, and INSYTE AUTOGUARD I.V. Catheters: named in the summary without a submission number

## Most influential descendants
- K020785: Introcan Safety IV Catheter (2002), 55 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
- K133856: Powerglide Midline Catheter (2014), 12 descendants of its own

## Recalls of this device
- Nov 26, 2018 · Class II · Z-0352-2020: Certain lots of the Model 306701 ProtectIV Plus Safety IV Catheter may exhibit damage on the safety mechanism guard.

## Indications for use
Johnson & Johnson Medical Intravascular Catheters are designed for single use. A properly placed I.V. catheter provides access to a vein or artery. These catheters may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused, and duration of therapy. 16 to 24 gauge catheters may be used with power injectors for which the maximum rated pressure is 300 psi.

Source page: https://510kreport.com/device/K990236
Methodology: https://510kreport.com/methodology