Cleared Traditional

ACCUPUMP 901 (MODEL NUMBERS 50 & 100) (K953382) - FDA 510(k) Clearance

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

K953382 · Pharmaceutical Infusion Technologies, Inc. · General Hospital
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Oct 1995
Decision
90d
Days
Class 2
Risk

K953382 is an FDA 510(k) clearance for the ACCUPUMP 901 (MODEL NUMBERS 50 & 100). Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Pharmaceutical Infusion Technologies, Inc. (Boulder, US). The FDA issued a Cleared decision on October 17, 1995 after a review of 90 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 Pharmaceutical Infusion Technologies, Inc. devices

Submission Details

510(k) Number K953382 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received July 19, 1995
Decision Date October 17, 1995
Days to Decision 90 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
39d faster than avg
Panel avg: 129d · This submission: 90d
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 232
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K953382.
ABBOTT XL3M INFUSION PUMP
K952799 · Abbott Laboratories · Jan 1996
VOLUMETRIC INFUSION PUMP
K953098 · Baxter Healthcare Corp · Dec 1995
PANCRETEC PROVIDER APM INFUSION PUMP (MODIFICATION)
K953731 · Abbott Laboratories · 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