Cleared Traditional

K864721 - CRYOTHERM

K864721 is an FDA 510(k) clearance for CRYOTHERM, manufactured by Grimm Scientific Industries, Inc.. The device is a Class 2 Physical Medicine device with product code ILJ cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K864721 · Grimm Scientific Industries, Inc. · Physical Medicine device
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Feb 1987
Decision
63d
Days
Class 2
Risk

K864721 is an FDA 510(k) clearance for the CRYOTHERM. Classified as Bath, Hydro-massage (product code ILJ), Class II - Special Controls.

Submitted by Grimm Scientific Industries, Inc. (Marietta, US). The FDA issued a Cleared decision on February 4, 1987 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5100 - 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.

FDA 510(k) Submission Details - K864721

510(k) Number K864721 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 1986
Decision Date February 04, 1987
Days to Decision 63 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 116d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ILJ Device Classification - Class 2, Special Controls

Product Code ILJ Bath, Hydro-massage
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5100
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 - ILJ Bath, Hydro-massage

All 72
Devices cleared under the same product code (ILJ) and FDA review panel - the closest regulatory comparables to K864721.
PARKER BATHING SYSTEM
K883308 · Mid-Canada Medical · Sep 1988
MODEL 938 BATHING SYSTEM
K880355 · Ferno Ille-Forge · Feb 1988
WHIRLPOOL AERATOR WB700, WB800, WB900, WB975
K872327 · Associated Mills, Inc. · Sep 1987
AQUA ARK, IMMERSION HYDROBATH
K861218 · Aqua Ark, Inc. · Apr 1986
SETMA HYGIA BATH MODEL ST 7200
K854861 · Setma, Inc. · Jan 1986
SETMA FHT, MODEL ST 8130
K854263 · Setma, Inc. · Nov 1985
K864721 · CRYOTHERM
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