Cleared Traditional

CENTAURSET 300 & 300 P.E.D (K830258) - FDA 510(k) Clearance

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

K830258 · Centaur Sciences, Inc. · General Hospital
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Feb 1983
Decision
21d
Days
Class 2
Risk

K830258 is an FDA 510(k) clearance for the CENTAURSET 300 & 300 P.E.D. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Centaur Sciences, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 15, 1983 after a review of 21 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 Centaur Sciences, Inc. devices

Submission Details

510(k) Number K830258 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 1983
Decision Date February 15, 1983
Days to Decision 21 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
108d faster than avg
Panel avg: 129d · This submission: 21d
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 238
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K830258.
STERILE IV SET 4 SIZES
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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