Cleared Traditional

K832123 - VENIPUNCTURE VALVE

K832123 is an FDA 510(k) clearance for VENIPUNCTURE VALVE, manufactured by Abbott Laboratories. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K832123 · Abbott Laboratories · General Hospital
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Aug 1983
Decision
43d
Days
Class 2
Risk

K832123 is an FDA 510(k) clearance for the VENIPUNCTURE VALVE. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on August 12, 1983 after a review of 43 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 Abbott Laboratories devices

FDA 510(k) Submission Details - K832123

510(k) Number K832123 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 1983
Decision Date August 12, 1983
Days to Decision 43 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 129d · This submission: 43d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FPA Device Classification - Class 2, Special Controls

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 532
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K832123.
INTRAVASCULAR ADMINISTRATION SET
K833030 · Gish Biomedical, Inc. · Nov 1983
INFUSION SETS #'S 124 & 142 PERSONAL
K831445 · Pacesetter Systems · Sep 1983
STERILE IV SET 4 SIZES
K832329 · Abco Dealers, Inc. · Aug 1983
SOLUTION ADMIN. SETS W/FLASHBALL
K831311 · Travenol Laboratories, S.A. · Jun 1983
SPECIALTY SET MODEL IV7A01
K830891 · Valleylab, Inc. · Apr 1983
INFUSION PUMP RETROGRADE EXTEN. AS 715
K830654 · Narco Scientific · Mar 1983