Cleared Traditional

K953382 - ACCUPUMP 901 (MODEL NUMBERS 50 & 100)

K953382 is an FDA 510(k) clearance for ACCUPUMP 901 (MODEL NUMBERS 50 & 100), manufactured by Pharmaceutical Infusion Technologies, Inc.. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 90-day FDA review.

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

FDA 510(k) Submission Details - K953382

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.

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 K953382.
PANCRETEC PROVIDER APM INFUSION PUMP (MODIFICATION)
K953731 · Abbott Laboratories · Dec 1995
SMARTDOSE IV PREFILLED INFUSION CONTAINER
K944351 · River Medical, Inc. · Nov 1995
SMARTDOSE III INFUSION CONTAINER
K944352 · River Medical, Inc. · Nov 1995
PLUM XL INFUSION PUMP (MODIFICATION)
K953660 · Abbott Laboratories · Oct 1995
DISETRONIC D-MODEM
K943952 · Disetronic Medical Systems · Oct 1995
ADI SYSTEM
K933825 · Abbott Laboratories · Sep 1995