NIPRO SAFETOUCH SCALP VEIN AND BLOOD COLLECTION SET— 510(k) K011297

Clearance details

Applicant

Nipro Medical Corp.

Product code

Code FOZ

Device class

Class 2

Regulation

21 CFR 880.5200

Advisory panel

General Hospital

Date received

2001-04-30

Decision date

2001-06-20

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Lexington, KY, US

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• 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

• K093985 — NIPRO SAFETOUCH LOCKTAIL SAFETY FISTULA NEEDLE2010-01-22
• K081210 — NIPRO SAFETOUCH HUBER INFUSTION SET2008-10-21
• K072024 — NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET, MODEL A201-A219, V801-V806, 5M9634, 5M96932007-10-04
• K063368 — NIPRO BIOHOLE NEEDLE2007-02-05
• K063721 — NIPRO SAFETOUCH II GAMMA2007-01-12

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-1834-2014 — NIPRO Safe Touch Safety Scalp Vein SetClass II·Terminated·Nipro Medical Corporation·20130504

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K011297.