Cleared Traditional

K771983 - SCALP VEIN SET

K771983 is the FDA 510(k) clearance for SCALP VEIN SET by Berman, Pcp & Consultants, Inc.. It is a Class 2 General Hospital device (product code FPA) cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K771983 · Berman, Pcp & Consultants, Inc. · General Hospital
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Jan 1978
Decision
79d
Days
Class 2
Risk

K771983 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 January 5, 1978 after a review of 79 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 K771983 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 1977
Decision Date January 05, 1978
Days to Decision 79 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
50d faster than avg
Panel avg: 129d · This submission: 79d
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 487
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K771983.
I.V. ADMINISTRATION SET WITH MINI-SPIKE
K780551 · National Patent Development Corp. · Apr 1978
I.V. LEVER CLAMP
K780481 · Travenol Laboratories, S.A. · Apr 1978
BURETTE INTRAVENOUS ADMIN. SETS.
K780130 · Y · Feb 1978
IN-LINE BURETTE SET
K772036 · Abbott Laboratories · Nov 1977
I.V. PUMP SET FOR FAT EMULSION
K771593 · Abbott Laboratories · Sep 1977
FLUID HANDLING DEVICE W/INPUT TUBING
K771453 · Imed Corp. · Aug 1977