Cleared Traditional

K771478 - INFUSION PUMP #6202

K771478 is the FDA 510(k) clearance for INFUSION PUMP #6202 by Roche Medical Electronics, Inc.. It is a Class 2 General Hospital device (product code FRN) cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K771478 · Roche Medical Electronics, Inc. · General Hospital
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Aug 1977
Decision
18d
Days
Class 2
Risk

K771478 is an FDA 510(k) clearance for the INFUSION PUMP #6202. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Roche Medical Electronics, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 22, 1977 after a review of 18 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 Roche Medical Electronics, Inc. devices

Submission Details

510(k) Number K771478 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 1977
Decision Date August 22, 1977
Days to Decision 18 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
111d faster than avg
Panel avg: 129d · This submission: 18d
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 307
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K771478.
IVAC 630 VOLUMETRIC INFUSION PUMP
K790373 · Y · Apr 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
INFUSION PUMP
K761151 · Travenol Laboratories, S.A. · Dec 1976