Cleared Traditional

K932071 - I.V. START KIT

K932071 is an FDA 510(k) clearance for I.V. START KIT, manufactured by Clinipad Corp.. The device is a Class 2 General Hospital device with product code FOZ cleared through the Traditional 510(k) pathway after a 295-day FDA review.

K932071 · Clinipad Corp. · General Hospital
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Feb 1994
Decision
295d
Days
Class 2
Risk

K932071 is an FDA 510(k) clearance for the I.V. START KIT. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Clinipad Corp. (Guilford, US). The FDA issued a Cleared decision on February 17, 1994 after a review of 295 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5200 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Clinipad Corp. devices

FDA 510(k) Submission Details - K932071

510(k) Number K932071 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received April 28, 1993
Decision Date February 17, 1994
Days to Decision 295 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
166d slower than avg
Panel avg: 129d · This submission: 295d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FOZ Device Classification - Class 2, Special Controls

Product Code FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5200
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days

All 340
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K932071.
PHARMACIA DELTEC PERIPHERALLY INSERTED VENOUS CATH
K926544 · Pharmacia Deltec, Inc. · Mar 1994
PICC INSERTION TRAY
K931668 · Clinipad Corp. · Mar 1994
I.V. START KIT
K931729 · Carapace, Inc. · Feb 1994
CHANGES TO PROTECTIV(TM) & JELCO(TM) WINGED CATH
K933050 · Critikon Company, LLC · Dec 1993
INTIMA POINT GUARD INTRAVASCULAR CATHETER
K923702 · Becton Dickinson Vascular Access, Inc. · Sep 1993
INTERMITTENT INJECTION SITE
K923323 · Kawasumi Laboratories Co., Ltd. · Jul 1993