Cleared Traditional

PANCRETEC PROVIDER APM INFUSION PUMP (MODIFICATION) (K953731) - FDA 510(k) Clearance

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

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

Submission Details

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.

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 235
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K953731.
COLLEAGUE 2 VOLUMETRIC INFUSION PUMP(DUAL CHANNEL)/COLLEAGUE 3 VOLUMETRIC INFUSION PUMP(TREE CHANNEL)
K961703 · Baxter Healthcare Corp · Jul 1996
ABBOTT XL3M INFUSION PUMP
K952799 · Abbott Laboratories · Jan 1996
VOLUMETRIC INFUSION PUMP
K953098 · Baxter Healthcare Corp · Dec 1995
PLUM XL INFUSION PUMP (MODIFICATION)
K953660 · Abbott Laboratories · Oct 1995
ADI SYSTEM
K933825 · Abbott Laboratories · Sep 1995
AUTO SYRINGE(R) AS50 INFUSION PUMP
K945942 · Baxter Healthcare Corp · Jul 1995