Cleared Traditional

K802335 - WHIRLPOOL BATHING UNIT-#2001

K802335 is an FDA 510(k) clearance for WHIRLPOOL BATHING UNIT-#2001, manufactured by Aqua Care Corp.. The device is a Class 2 Physical Medicine device with product code ILJ cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K802335 · Aqua Care Corp. · Physical Medicine device
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Oct 1980
Decision
17d
Days
Class 2
Risk

K802335 is an FDA 510(k) clearance for the WHIRLPOOL BATHING UNIT-#2001. Classified as Bath, Hydro-massage (product code ILJ), Class II - Special Controls.

Submitted by Aqua Care Corp. (Walker, US). The FDA issued a Cleared decision on October 10, 1980 after a review of 17 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 - K802335

510(k) Number K802335 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 1980
Decision Date October 10, 1980
Days to Decision 17 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
99d faster than avg
Panel avg: 116d · This submission: 17d
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 71
Devices cleared under the same product code (ILJ) and FDA review panel - the closest regulatory comparables to K802335.
CENTURY HYDROTHERAPY PUMP
K811903 · Century Manufacturing Co. · Jul 1981
CENTURY HYDRO-SAN THERAPY TANK
K811904 · Century Manufacturing Co. · Jul 1981
FOOT BATHS & HAND MASSAGERS
K810034 · Associated Mills, Inc. · Jan 1981
SEARS 5 FOOT ACRYLIC BATHTUB/WHIRLPOOL
K791718 · Universal-Kundle Corp. · Oct 1979
GILLETTE CORDLESS WHIRLPOOL
K791603 · The Gillette Company · Sep 1979
VIBRO BATH MODEL FS-1
K771966 · Dazey Products Co. · Nov 1977
K802335 · WHIRLPOOL BATHING UNIT-#2001
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