Cleared Traditional

K913931 - PANCRETEC PROVIDER MODEL 5500 INFUS PUMP

K913931 is an FDA 510(k) clearance for PANCRETEC PROVIDER MODEL 5500 INFUS PUMP, 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 188-day FDA review.

K913931 · Abbott Laboratories · General Hospital
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Mar 1992
Decision
188d
Days
Class 2
Risk

K913931 is an FDA 510(k) clearance for the PANCRETEC PROVIDER(R) MODEL 5500 INFUS PUMP, MODIF. 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 March 4, 1992 after a review of 188 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 Abbott Laboratories devices

FDA 510(k) Submission Details - K913931

510(k) Number K913931 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 1991
Decision Date March 04, 1992
Days to Decision 188 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
59d slower than avg
Panel avg: 129d · This submission: 188d
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 K913931.
AVI MODEL 275CI INFUSION PUMP
K920680 · 3M Health Care, Ltd. · Apr 1992
AVI MODEL 285CI INFUSION PUMP
K920681 · 3M Health Care, Ltd. · Apr 1992
FLO-GARD 8000 HALF-SET
K915499 · Baxter Healthcare Corp · Mar 1992
FLO-GARD(R) 6201
K915522 · Baxter Healthcare Corp · Feb 1992
FLO-GARD(R) 6301
K915523 · Baxter Healthcare Corp · Feb 1992
PROVIDER APM INFUSION PUMP
K914349 · Abbott Laboratories · Dec 1991