Cleared Traditional

K822354 - DISPOSABLE PLASTIC TRANSFUS./INFUS. ASSB

K822354 is an FDA 510(k) clearance for DISPOSABLE PLASTIC TRANSFUS./INFUS. ASSB, manufactured by Valleylab, Inc.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K822354 · Valleylab, Inc. · General Hospital
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Sep 1982
Decision
47d
Days
Class 2
Risk

K822354 is an FDA 510(k) clearance for the DISPOSABLE PLASTIC TRANSFUS./INFUS. ASSB. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Valleylab, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 22, 1982 after a review of 47 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 Valleylab, Inc. devices

FDA 510(k) Submission Details - K822354

510(k) Number K822354 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 1982
Decision Date September 22, 1982
Days to Decision 47 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
82d faster than avg
Panel avg: 129d · This submission: 47d
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 512
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K822354.
MACRODOT ADD-I-MED ADMIN. SET
K823347 · Imed Corp. · Nov 1982
ACCUDOT 380 SECONDARY I.V. SET
K823027 · Imed Corp. · Nov 1982
INFUS. SETS-9120-50 CM & 9121-100 CM,EXT
K822775 · Cardiac Pacemakers, Inc. · Nov 1982
AS 700 SERIES INFUSION PUMP ADMIN.
K821377 · Narco Scientific · Jul 1982
DESERET E-Z SET INFUSION SET
K821750 · Warner-Lambert Co. · Jul 1982
VENOSET DUAL-RATE PIGGYBACK W/IVEX &
K821578 · Abbott Laboratories · Jun 1982