Cleared Traditional

K875082 - O.P.C. INTRAVASCULAR CATHETER

K875082 is an FDA 510(k) clearance for O.P.C. INTRAVASCULAR CATHETER, manufactured by Taut, Inc.. The device is a Class 2 General Hospital device with product code FOZ cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K875082 · Taut, Inc. · General Hospital
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Mar 1988
Decision
90d
Days
Class 2
Risk

K875082 is an FDA 510(k) clearance for the O.P.C. INTRAVASCULAR CATHETER. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Taut, Inc. (Geneva, US). The FDA issued a Cleared decision on March 8, 1988 after a review of 90 days - within the typical 510(k) review window.

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 Taut, Inc. devices

FDA 510(k) Submission Details - K875082

510(k) Number K875082 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1987
Decision Date March 08, 1988
Days to Decision 90 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 129d · This submission: 90d
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 405
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K875082.
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K881215 · Baxter Healthcare Corp · Jun 1988
TORAY ANTHRON P-U CATHETERS
K881236 · Toray Industries (America), Inc. · May 1988
HR(TM) INTRAVASCULAR CATHETER
K881666 · Icu Medical, Inc. · May 1988
J&J SCALP VEIN INFUSION SETS
K875177 · Critikon Company, LLC · Jan 1988
DESERET SPLITTABLE CATHETER
K874582 · Deseret Medical, Inc. · Dec 1987
VASCULAR ACCESS CATHETER W/ANTIMICROBIAL CUFF
K873050 · C.R. Bard, Inc. · Oct 1987