Cleared Traditional

K791293 - BATTERY POWERED SYRINGE INFUSION PUMP

K791293 is an FDA 510(k) clearance for BATTERY POWERED SYRINGE INFUSION PUMP, manufactured by Harvard Apparatus, Inc.. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K791293 · Harvard Apparatus, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K791293

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.

FRN Device Classification - Class 2, Special Controls

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 528
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K791293.
HEPARIN PUMP #7420
K800570 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1980
3M SMALL VOLUME INFUSTION (SVI) SYSTEM
K792050 · 3M Company · Mar 1980
MODEL IV 6500 FORMULATOR
K792142 · Valleylab, Inc. · Nov 1979
FLEXIFO ENTERAL NUTRITION PUMP
K791528 · Abbott Laboratories · Sep 1979
ALARM
K790559 · Maddak, Inc. · Jun 1979
MODEL 113 TREONIC IP3 DIGITAL SYRINGE PU
K790945 · Vickers America Medical Corp. · Jun 1979