Cleared Traditional

K821809 - THERMOFONTE AIR MESSAGE BATH

K821809 is an FDA 510(k) clearance for THERMOFONTE AIR MESSAGE BATH, manufactured by Greenfields. The device is a Class 2 Chemistry device with product code ILJ cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K821809 · Greenfields · Chemistry device
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Jul 1982
Decision
35d
Days
Class 2
Risk

K821809 is an FDA 510(k) clearance for the THERMOFONTE AIR MESSAGE BATH. Classified as Bath, Hydro-massage (product code ILJ), Class II - Special Controls.

Submitted by Greenfields (Mchenry, US). The FDA issued a Cleared decision on July 23, 1982 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 890.5100 - the FDA in vitro diagnostics and chemistry 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 Greenfields devices

FDA 510(k) Submission Details - K821809

510(k) Number K821809 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 1982
Decision Date July 23, 1982
Days to Decision 35 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 88d · This submission: 35d
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 Chemistry devices follow this clearance model.

Regulatory Peers - ILJ Bath, Hydro-massage

All 15
Devices cleared under the same product code (ILJ) and FDA review panel - the closest regulatory comparables to K821809.
XTANK2 MOBILE EXTREMITY WHIRLPOOL SYSTEM
K971592 · The Silcraft Corp. · Feb 1998
SILCRAFT ACCESS 3700 WHIRLPOOL SYSTEM, SILCRAFT MODEL 1800 LIFT, SILCRAFT DISINFECTANT
K971593 · The Silcraft Corp. · Feb 1998
BATH AIR SPA FIXED HEIGHT HYDRAULIC OPERATED/ADJUSTABLE HEIGHT HYDRAULIC/FIXED HEIGHT ELECTRIC RECLINING/HEIGHT ELECTRIC
K964926 · Joerns Healthcare, Inc. · Nov 1997