MODIFICATION OF JELCO*,JELCO*-W AND JELCO* PLUS I.V. CATHETERS, CATHLON* I.V. CATHETERS, OPTIVA* I.V. CATHETERS, PROTECT— 510(k) K990236

Clearance details

Applicant

Johnson & Johnson Medical, Div. of Ethicon, Inc.

Product code

Code FOZ

Device class

Class 2

Regulation

21 CFR 880.5200

Advisory panel

General Hospital

Date received

1999-01-25

Decision date

1999-08-20

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Arlington, TX, US

• K260432 — Ruby Intravascular Catheter2026-09-02
• K260165 — Unimpregnated Central Venous Catheter2026-08-10
• K261041 — ClearSafe Closed System2026-07-10
• K260539 — MedSource QuickSafe Safety IV Catheter; MedSource PurSafe Safety IV Catheter2026-07-09
• K253235 — Introcan Safety® Deep Access XL IV Catheter2026-05-15

• K990395 — BARRIER SURGICAL GOWNS1999-04-13
• K983240 — NEUTRALON PF POWDER FREE BROWN LATEX SURGICAL GLOVES1998-11-30
• K983234 — TIELLE PLUS HYDROPOLYMER ADHESIVE DRESSING1998-11-25
• K983394 — MODIFICATION TO TIELLE HYDROPOLMER DRESSING1998-11-03

Death

38

Injury

2,290

Malfunction

25,858

Other

11

Total

28,197

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-0352-2020 — ProtectIV¿ Plus Safety IV Catheter, sterile. Packaged in a pouch and than into an inner carton.Class II·Terminated·Smiths Medical ASD Inc.·20181126

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K990236.