Cleared Traditional

INFUSION PUMP #AS*6H (K830486) - FDA 510(k) Clearance

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

K830486 · Baxter Healthcare Corp · General Hospital
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Apr 1983
Decision
58d
Days
Class 2
Risk

K830486 is an FDA 510(k) clearance for the INFUSION PUMP #AS*6H. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Walker, US). The FDA issued a Cleared decision on April 14, 1983 after a review of 58 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - 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 K830486 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 1983
Decision Date April 14, 1983
Days to Decision 58 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
71d faster than avg
Panel avg: 129d · This submission: 58d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FRN Pump, Infusion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
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 - FRN Pump, Infusion

All 219
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K830486.
FLO-GARD 6100 VOLUMETRIC INFUSION PUMP
K831258 · Travenol Laboratories, S.A. · Jun 1983
Y-TYPE BACKCHECK MICROBORE EXTEN. SET
K831203 · Abbott Laboratories · Jun 1983
PCA PUMP
K830452 · Abbott Laboratories · Apr 1983
GRASE BY DYNAMICS MS 27 SYRINGE DRIVER
K830809 · Intermedics, Inc. · Apr 1983
SYRINGE DRIVER MS-16
K830423 · Intermedics, Inc. · Mar 1983
HARVARD APPARATUS INTERMITTENT INFUSION
K830102 · C.R. Bard, Inc. · Feb 1983