Cleared Traditional

K952794 - HARVARD 2 SYRINGE PUMP

K952794 is an FDA 510(k) clearance for HARVARD 2 SYRINGE 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 88-day FDA review.

K952794 · Harvard Apparatus, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 1995
Decision
88d
Days
Class 2
Risk

K952794 is an FDA 510(k) clearance for the HARVARD 2 SYRINGE PUMP. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Harvard Apparatus, Inc. (South Natick, US). The FDA issued a Cleared decision on September 15, 1995 after a review of 88 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.

FDA 510(k) Submission Details - K952794

510(k) Number K952794 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 1995
Decision Date September 15, 1995
Days to Decision 88 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 129d · This submission: 88d
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 694
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K952794.
DISETRONIC D-MODEM
K943952 · Disetronic Medical Systems · Oct 1995
MODEL 1100 MEDMATE INFUSION PUMP
K953270 · Patient Solutions, Inc. · Oct 1995
ADI SYSTEM
K933825 · Abbott Laboratories · Sep 1995
9000 INFUSION PUMP
K944721 · Graseby Medical , Ltd. · Aug 1995
FLEXIFLO QUANTUM ENTERAL PUMP
K944669 · Abbott Mfg., Inc. · Jul 1995
AUTO SYRINGE(R) AS50 INFUSION PUMP
K945942 · Baxter Healthcare Corp · Jul 1995
K952794 · HARVARD 2 SYRINGE PUMP
Download PDF FDA Summary Harvard Apparatus, In…