Cleared Traditional

K952967 - UNIMED MEDICAL DISPENSING PUMP

K952967 is an FDA 510(k) clearance for UNIMED MEDICAL DISPENSING PUMP, manufactured by A.Z.E. Medical, Inc.. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 227-day FDA review.

K952967 · A.Z.E. Medical, Inc. · General Hospital
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Feb 1996
Decision
227d
Days
Class 2
Risk

K952967 is an FDA 510(k) clearance for the UNIMED MEDICAL DISPENSING PUMP. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by A.Z.E. Medical, Inc. (Palm Harobor, US). The FDA issued a Cleared decision on February 9, 1996 after a review of 227 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 A.Z.E. Medical, Inc. devices

FDA 510(k) Submission Details - K952967

510(k) Number K952967 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 1995
Decision Date February 09, 1996
Days to Decision 227 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
98d slower than avg
Panel avg: 129d · This submission: 227d
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 582
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K952967.
DISETRONIC MULTIFUSE PUMP SYSTEM
K954826 · Disetronic Medical Systems · May 1996
CADD-PCA, -MICRO, -PRIZM AMBULATORY INFUSION PUMP
K955180 · Sims Deltec, Inc. · May 1996
THE IMED AMBULATORY INFUSION PUMP, ADMINISTRATION SETS
K953896 · Imed Corp. · Mar 1996
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