Cleared Traditional

INFUSION PUMP-MODEL 2616 (K780705) - FDA 510(k) Clearance

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

K780705 · Harvard Apparatus, Inc. · General Hospital
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May 1978
Decision
24d
Days
Class 2
Risk

K780705 is an FDA 510(k) clearance for the INFUSION PUMP-MODEL 2616. 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 May 19, 1978 after a review of 24 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 Harvard Apparatus, Inc. devices

Submission Details

510(k) Number K780705 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 1978
Decision Date May 19, 1978
Days to Decision 24 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
105d faster than avg
Panel avg: 129d · This submission: 24d
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 K780705.
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
LIFECARE I.V. PUMP - MODEL III
K772094 · Abbott Laboratories · Dec 1977
I.V. PUMP, ABBOTT/SHAW LIFECARE
K770087 · Abbott Laboratories · Feb 1977
AUTO SYRINGE MODEL AS-3A
K761307 · Baxter Healthcare Corp · Jan 1977