Cleared Traditional

K782034 - INFUSION PUMP

K782034 is the FDA 510(k) clearance for INFUSION PUMP by Baxter Healthcare Corp. It is a Class 2 General Hospital device (product code FRN) cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K782034 · Baxter Healthcare Corp · General Hospital
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Feb 1979
Decision
83d
Days
Class 2
Risk

K782034 is an FDA 510(k) clearance for the INFUSION PUMP, MODEL AS*5. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Mchenry, US). The FDA issued a Cleared decision on February 27, 1979 after a review of 83 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 K782034 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 1978
Decision Date February 27, 1979
Days to Decision 83 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
46d faster than avg
Panel avg: 129d · This submission: 83d
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 443
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K782034.
BLOOD CELL SEPARATOR SYSTEM CS3000
K790315 · Travenol Laboratories, S.A. · May 1979
MODEL IV6000 INFUSION PUMP
K790332 · Valleylab, Inc. · Apr 1979
IVAC 630 VOLUMETRIC INFUSION PUMP
K790373 · Y · Apr 1979
INFUSION PUMP, PEDIATRIC MODEL 301
K781171 · Imed Corp. · Aug 1978
INFUSION PUMP
K780503 · Air-Shields, Inc. · Apr 1978
INFUSION APPARATUS, POWERED
K780086 · Ohio Medical Products · Jan 1978