Cleared Traditional

SCALP VEIN SET (K771271) - FDA 510(k) Clearance

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

K771271 · Berman, Pcp & Consultants, Inc. · General Hospital
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Sep 1977
Decision
84d
Days
Class 2
Risk

K771271 is an FDA 510(k) clearance for the SCALP VEIN SET. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Berman, Pcp & Consultants, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 12, 1977 after a review of 84 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - 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 Berman, Pcp & Consultants, Inc. devices

Submission Details

510(k) Number K771271 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 1977
Decision Date September 12, 1977
Days to Decision 84 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
45d faster than avg
Panel avg: 129d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FPA Set, Administration, Intravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
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 - FPA Set, Administration, Intravascular

All 208
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K771271.
BURETTE SET WITH AIR CONTROL LEVER
K780970 · Travenol Laboratories, S.A. · Jul 1978
I.V. LEVER CLAMP
K780481 · Travenol Laboratories, S.A. · Apr 1978
IN-LINE BURETTE SET
K772036 · Abbott Laboratories · Nov 1977
I.V. PUMP SET FOR FAT EMULSION
K771593 · Abbott Laboratories · Sep 1977
SOLUSET FOR IV FAT EMULSION
K770743 · Abbott Laboratories · Jun 1977
BURETTE SET, 2C0132
K770763 · Travenol Laboratories, S.A. · Jun 1977