Cleared Traditional

RIVER PUMP (K932895) - FDA 510(k) Clearance

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

K932895 · River Medical, Inc. · General Hospital
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Mar 1994
Decision
290d
Days
Class 2
Risk

K932895 is an FDA 510(k) clearance for the RIVER PUMP. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by River Medical, Inc. (San Diego, US). The FDA issued a Cleared decision on March 31, 1994 after a review of 290 days - an extended review 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: 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 River Medical, Inc. devices

Submission Details

510(k) Number K932895 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 1993
Decision Date March 31, 1994
Days to Decision 290 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
161d slower than avg
Panel avg: 129d · This submission: 290d
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 221
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K932895.
ABBOTT LTE INFUSION PUMP
K944125 · Abbott Laboratories · Dec 1994
PROVIDER ANNE INFUSER
K922702 · Abbott Laboratories · Jul 1994
BARD APII PUMP
K926385 · C.R. Bard, Inc. · Apr 1994
HI-FLO INFUSION PUMP
K934671 · Abbott Laboratories · Mar 1994
BARD 500ML RESERVOIR HOLDER
K915649 · C.R. Bard, Inc. · Mar 1994
KVOI.V. FLUSH SYSTEM
K923224 · Baxter Healthcare Corp · Feb 1994