Cleared Traditional

K841922 - ACCUPRO VOLUMETRIC INFUSION PUMP W/RS232

K841922 is the FDA 510(k) clearance for ACCUPRO VOLUMETRIC INFUSION PUMP W/RS232 by American Edwards Laboratories. It is a Class 2 General Hospital device (product code FRN) cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K841922 · American Edwards Laboratories · General Hospital
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Jul 1984
Decision
64d
Days
Class 2
Risk

K841922 is an FDA 510(k) clearance for the ACCUPRO VOLUMETRIC INFUSION PUMP W/RS232. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by American Edwards Laboratories (Mchenry, US). The FDA issued a Cleared decision on July 13, 1984 after a review of 64 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 American Edwards Laboratories devices

Submission Details

510(k) Number K841922 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 1984
Decision Date July 13, 1984
Days to Decision 64 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
65d faster than avg
Panel avg: 129d · This submission: 64d
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 433
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K841922.
MODULAR VOLUMETRIC INFUSION PUMP SYS
K843274 · American Edwards Laboratories · Oct 1984
ARGYLE ENTERITE ENTERAL FEEDING PUMP
K842421 · Sherwood Medical Co. · Aug 1984
IVAC 3080 ENTERAL FEEDING PUMP
K842027 · Y · Jul 1984
FLEXIFLO-III PORTABLE ENTERAL NUTRI
K841784 · Abbott Laboratories · Jun 1984
LIFECARE 4/HOMECARE - 4H PUMP
K840263 · Abbott Laboratories · Feb 1984
GILLETTE SABRE SYRINGE
K833655 · Intermedics, Inc. · Dec 1983