Cleared Traditional

BATTERY POWERED SYRINGE INFUSION PUMP (K791293) - FDA 510(k) Clearance

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

K791293 · Harvard Apparatus, Inc. · General Hospital
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Nov 1979
Decision
126d
Days
Class 2
Risk

K791293 is an FDA 510(k) clearance for the BATTERY POWERED SYRINGE INFUSION PUMP. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Harvard Apparatus, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 13, 1979 after a review of 126 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Harvard Apparatus, Inc. devices

Submission Details

510(k) Number K791293 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 1979
Decision Date November 13, 1979
Days to Decision 126 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
3d faster than avg
Panel avg: 129d · This submission: 126d
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 232
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K791293.
INTRAVENOUS INFUSION PUMP, CODE 2M8015
K800629 · Travenol Laboratories, S.A. · May 1980
HEPARIN PUMP #7420
K800570 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1980
3M SMALL VOLUME INFUSTION (SVI) SYSTEM
K792050 · 3M Company · Mar 1980
FLEXIFO ENTERAL NUTRITION PUMP
K791528 · Abbott Laboratories · Sep 1979
BLOOD CELL SEPARATOR SYSTEM CS3000
K790315 · Travenol Laboratories, S.A. · May 1979
INFUSION PUMP, MODEL AS*5
K782034 · Baxter Healthcare Corp · Feb 1979