Cleared Traditional

J&J SCALP VEIN INFUSION SETS (K875177) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K875177 · Critikon Company, LLC · General Hospital
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Jan 1988
Decision
23d
Days
Class 2
Risk

K875177 is an FDA 510(k) clearance for the J&J SCALP VEIN INFUSION SETS. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Critikon Company, LLC (Tampa, US). The FDA issued a Cleared decision on January 14, 1988 after a review of 23 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Critikon Company, LLC devices

Submission Details

510(k) Number K875177 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 1987
Decision Date January 14, 1988
Days to Decision 23 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
106d faster than avg
Panel avg: 129d · This submission: 23d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 139
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K875177.
VASCULON 2 INTRAVENOUS CANNULA
K883415 · Ohmeda Medical · Oct 1988
VIGGO INSUFLON
K881767 · Ohmeda Medical · Aug 1988
CENTRASIL SILICONE ELASTOMER CENTRAL VENOUS CATH
K881215 · Baxter Healthcare Corp · Jun 1988
VASCULAR ACCESS CATHETER W/ANTIMICROBIAL CUFF
K873050 · C.R. Bard, Inc. · Oct 1987
INSTRUCTION CHANGE FOR RIGHT ATRIAL/RAAF CATHETER
K864949 · Quinton, Inc. · Feb 1987
ARROW 18GA TWO-LUMEN INTRAVENOUS CATH/23GA NEEDLE
K862153 · Arrow Intl., Inc. · Dec 1986