Cleared Traditional

K912004 - SHEPARD CRYOPRESS/CAMP MULTI-TEMP SPORT PUMPS

K912004 is an FDA 510(k) clearance for SHEPARD CRYOPRESS/CAMP MULTI-TEMP SPORT..., manufactured by Shepherd Medical Products, Inc.. The device is a Class 2 Physical Medicine device with product code IRP cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K912004 · Shepherd Medical Products, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1991
Decision
80d
Days
Class 2
Risk

K912004 is an FDA 510(k) clearance for the SHEPARD CRYOPRESS/CAMP MULTI-TEMP SPORT PUMPS. Classified as Massager, Powered Inflatable Tube (product code IRP), Class II - Special Controls.

Submitted by Shepherd Medical Products, Inc. (Washington, US). The FDA issued a Cleared decision on July 25, 1991 after a review of 80 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5650 - the FDA physical medicine 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Shepherd Medical Products, Inc. devices

FDA 510(k) Submission Details - K912004

510(k) Number K912004 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 1991
Decision Date July 25, 1991
Days to Decision 80 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 115d · This submission: 80d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IRP Device Classification - Class 2, Special Controls

Product Code IRP Massager, Powered Inflatable Tube
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5650
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 Physical Medicine devices follow this clearance model.

Regulatory Peers - IRP Massager, Powered Inflatable Tube

All 132
Devices cleared under the same product code (IRP) and FDA review panel - the closest regulatory comparables to K912004.
ATLANT'S
K974395 · Grad-Line Corp. · Oct 1998
INTERMITTENT COMPRESSOR SYSTEM
K964957 · Eischoco, Inc. · Feb 1997
BIO BOOST
K961426 · Bio Compression Systems, Inc. · Oct 1996
FLOWTRON AC200/2
K874688 · Huntleigh Technology, Inc. · Sep 1988
EBI HAND MASSAGING PUMP (HMP)
K860632 · Electro-Biology, Inc. · Apr 1986
EBI FOOT MASSAGING PUMP
K852264 · Electro-Biology, Inc. · Jul 1985