Cleared Traditional

LOW VOLUME INFUSTION SET (K821624) - FDA 510(k) Clearance

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

K821624 · Lifemed of California · General Hospital
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Jun 1982
Decision
20d
Days
Class 2
Risk

K821624 is an FDA 510(k) clearance for the LOW VOLUME INFUSTION SET. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Lifemed of California (Mchenry, US). The FDA issued a Cleared decision on June 22, 1982 after a review of 20 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 Lifemed of California devices

Submission Details

510(k) Number K821624 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 1982
Decision Date June 22, 1982
Days to Decision 20 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
109d faster than avg
Panel avg: 129d · This submission: 20d
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 K821624.
VENIPUNCTURE VALVE
K832123 · Abbott Laboratories · Aug 1983
SOLUTION ADMIN. SETS W/FLASHBALL
K831311 · Travenol Laboratories, S.A. · Jun 1983
VENOSET DUAL-RATE PIGGYBACK W/IVEX &
K821578 · Abbott Laboratories · Jun 1982
VENTED NITROGLYCERIN I.V. SET
K821515 · Abbott Laboratories · Jun 1982
MONOJECT SAF-T-LOCK
K820747 · Sherwood Medical Co. · Apr 1982
AUTO-SYRINGE SUB-CUTEANEOUS SET
K813194 · Baxter Healthcare Corp · Dec 1981