Cleared Traditional

K931458 - MEDIPAK AMBULATORY INFUSION PUMP

K931458 is an FDA 510(k) clearance for MEDIPAK AMBULATORY INFUSION PUMP, manufactured by Medication Delivery Devices, Inc.. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 373-day FDA review.

K931458 · Medication Delivery Devices, Inc. · General Hospital
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Mar 1994
Decision
373d
Days
Class 2
Risk

K931458 is an FDA 510(k) clearance for the MEDIPAK AMBULATORY INFUSION PUMP. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Medication Delivery Devices, Inc. (San Diego, US). The FDA issued a Cleared decision on March 31, 1994 after a review of 373 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 Medication Delivery Devices, Inc. devices

FDA 510(k) Submission Details - K931458

510(k) Number K931458 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 1993
Decision Date March 31, 1994
Days to Decision 373 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
244d slower than avg
Panel avg: 129d · This submission: 373d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FRN Device Classification - Class 2, Special Controls

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 612
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K931458.
PROVIDER ANNE INFUSER
K922702 · Abbott Laboratories · Jul 1994
CORPAK ENTERAL PUMP
K932847 · Corpak Co. · Jun 1994
BARD APII PUMP
K926385 · C.R. Bard, Inc. · Apr 1994
RIVER PUMP
K932895 · River Medical, Inc. · Mar 1994
VIVUS 5000 INFUSION SYSTEM
K924527 · I-Flow Corp. · Mar 1994
HI-FLO INFUSION PUMP
K934671 · Abbott Laboratories · Mar 1994