Cleared Traditional

AUTO-SYRINGE MICRO VOLUME EXTENSION SET (K811463) - FDA 510(k) Clearance

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

K811463 · Baxter Healthcare Corp · General Hospital
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Jun 1981
Decision
17d
Days
Class 2
Risk

K811463 is an FDA 510(k) clearance for the AUTO-SYRINGE MICRO VOLUME EXTENSION SET. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Mchenry, US). The FDA issued a Cleared decision on June 12, 1981 after a review of 17 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 Baxter Healthcare Corp devices

Submission Details

510(k) Number K811463 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 1981
Decision Date June 12, 1981
Days to Decision 17 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
112d faster than avg
Panel avg: 129d · This submission: 17d
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 207
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K811463.
AUTO-SYRINGE SUB-CUTEANEOUS SET
K813194 · Baxter Healthcare Corp · Dec 1981
INTRAVENOUS ADMINISTRATION SET
K812231 · Cordis Corp. · Aug 1981
RADIATION STERILIZED ADMIN. SET
K811078 · Travenol Laboratories, S.A. · Jul 1981
VENTED PRIMARY PIGGYBACK VENOSET DUAL
K810239 · Abbott Laboratories · May 1981
NITROGLYCERINE IV SET
K810317 · Abbott Laboratories · May 1981
VOLUMETRIC PUMP CASSETTE W/ATTACHED SET
K800711 · Travenol Laboratories, S.A. · May 1980