Cleared Traditional

K791566 - MODEL AS* 6C INFUSION PUMP

K791566 is an FDA 510(k) clearance for MODEL AS* 6C INFUSION PUMP, manufactured by Baxter Healthcare Corp. The device is a Class 1 General Hospital device with product code FRW cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K791566 · Baxter Healthcare Corp · General Hospital
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Nov 1979
Decision
95d
Days
Class 1
Risk

K791566 is an FDA 510(k) clearance for the MODEL AS* 6C INFUSION PUMP. Classified as Scale, Patient (product code FRW), Class I - General Controls.

Submitted by Baxter Healthcare Corp (Mchenry, US). The FDA issued a Cleared decision on November 13, 1979 after a review of 95 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2720 - 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 Baxter Healthcare Corp devices

FDA 510(k) Submission Details - K791566

510(k) Number K791566 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 1979
Decision Date November 13, 1979
Days to Decision 95 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 129d · This submission: 95d
Pathway characteristics
Predicate-based equivalence.

FRW Device Classification - Class 1, General Controls

Product Code FRW Scale, Patient
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.2720
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.