Cleared Traditional

K932847 - CORPAK ENTERAL PUMP

K932847 is the FDA 510(k) clearance for CORPAK ENTERAL PUMP by Corpak Co.. It is a Class 2 General Hospital device (product code FRN) cleared through the Traditional 510(k) pathway after a 372-day FDA review.

K932847 · Corpak Co. · General Hospital
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Jun 1994
Decision
372d
Days
Class 2
Risk

K932847 is an FDA 510(k) clearance for the CORPAK ENTERAL PUMP. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Corpak Co. (Wheeling, US). The FDA issued a Cleared decision on June 17, 1994 after a review of 372 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Corpak Co. devices

Submission Details

510(k) Number K932847 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received June 10, 1993
Decision Date June 17, 1994
Days to Decision 372 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
243d slower than avg
Panel avg: 129d · This submission: 372d
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 K932847.
PLUM XL INFUSION PUMP
K944733 · Abbott Laboratories · Feb 1995
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