Cleared Traditional

K953731 - PANCRETEC PROVIDER APM INFUSION PUMP (M...

K953731 is an FDA 510(k) clearance for PANCRETEC PROVIDER APM INFUSION PUMP (M..., manufactured by Abbott Laboratories. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K953731 · Abbott Laboratories · General Hospital
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Dec 1995
Decision
127d
Days
Class 2
Risk

K953731 is an FDA 510(k) clearance for the PANCRETEC PROVIDER APM INFUSION PUMP (MODIFICATION). Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on December 13, 1995 after a review of 127 days - within the typical 510(k) review window.

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 Abbott Laboratories devices

FDA 510(k) Submission Details - K953731

510(k) Number K953731 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 1995
Decision Date December 13, 1995
Days to Decision 127 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
2d faster than avg
Panel avg: 129d · This submission: 127d
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 459
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K953731.
THE IMED AMBULATORY INFUSION PUMP, ADMINISTRATION SETS
K953896 · Imed Corp. · Mar 1996
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K952799 · Abbott Laboratories · Jan 1996
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K953098 · Baxter Healthcare Corp · Dec 1995
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K953660 · Abbott Laboratories · Oct 1995
ADI SYSTEM
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K945942 · Baxter Healthcare Corp · Jul 1995