Cleared Traditional

K955853 - HEALTHCARE SERVICE & SUPPLY PUMP ALP 501 PUMP SYSTEM

K955853 is an FDA 510(k) clearance for HEALTHCARE SERVICE & SUPPLY PUMP ALP 50..., manufactured by Healthcare Service and Supply. The device is a Class 2 Cardiovascular device with product code JOW cleared through the Traditional 510(k) pathway after a 187-day FDA review.

K955853 · Healthcare Service and Supply · Cardiovascular device
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Jun 1996
Decision
187d
Days
Class 2
Risk

K955853 is an FDA 510(k) clearance for the HEALTHCARE SERVICE & SUPPLY PUMP ALP 501 PUMP SYSTEM. Classified as Sleeve, Limb, Compressible (product code JOW), Class II - Special Controls.

Submitted by Healthcare Service and Supply (Tustin, US). The FDA issued a Cleared decision on June 25, 1996 after a review of 187 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5800 - the FDA cardiovascular device oversight 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 Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Healthcare Service and Supply devices

FDA 510(k) Submission Details - K955853

510(k) Number K955853 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 1995
Decision Date June 25, 1996
Days to Decision 187 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
62d slower than avg
Panel avg: 125d · This submission: 187d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JOW Device Classification - Class 2, Special Controls

Product Code JOW Sleeve, Limb, Compressible
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5800
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - JOW Sleeve, Limb, Compressible

All 326
Devices cleared under the same product code (JOW) and FDA review panel - the closest regulatory comparables to K955853.
EUREDUC PNEUMATIC DRAINAGE SYSTEM
K954788 · Eureduc · Oct 1996
FLOWTRON EXCEL PUMP
K961166 · Hne Healthcare, Inc. · Oct 1996
EUREDUC PNEUMATIC DRAINAGE SYSTEM MODEL TP03
K960902 · Eureduc · Sep 1996
M.I.C.
K950967 · V.V.T. Healthcare Technologies, Inc. · May 1996
REDOX
K953850 · Kinetic Concepts, Inc. · Mar 1996
ART-ASSIST MODEL AA-1000
K942530 · Aci Medical, Inc. · Feb 1996