Cleared Traditional

K791718 - SEARS 5 FOOT ACRYLIC BATHTUB/WHIRLPOOL

K791718 is an FDA 510(k) clearance for SEARS 5 FOOT ACRYLIC BATHTUB/WHIRLPOOL, manufactured by Universal-Kundle Corp.. The device is a Class 2 Physical Medicine device with product code ILJ cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K791718 · Universal-Kundle Corp. · Physical Medicine device
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Oct 1979
Decision
37d
Days
Class 2
Risk

K791718 is an FDA 510(k) clearance for the SEARS 5 FOOT ACRYLIC BATHTUB/WHIRLPOOL. Classified as Bath, Hydro-massage (product code ILJ), Class II - Special Controls.

Submitted by Universal-Kundle Corp. (Mchenry, US). The FDA issued a Cleared decision on October 4, 1979 after a review of 37 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 - K791718

510(k) Number K791718 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 1979
Decision Date October 04, 1979
Days to Decision 37 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 116d · This submission: 37d
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 K791718.
CENTURY HYDRO-SAN THERAPY TANK
K811904 · Century Manufacturing Co. · Jul 1981
FOOT BATHS & HAND MASSAGERS
K810034 · Associated Mills, Inc. · Jan 1981
WHIRLPOOL BATHING UNIT-#2001
K802335 · Aqua Care Corp. · Oct 1980
GILLETTE CORDLESS WHIRLPOOL
K791603 · The Gillette Company · Sep 1979
VIBRO BATH MODEL FS-1
K771966 · Dazey Products Co. · Nov 1977
TURBO-JET MODEL 76
K771969 · Dazey Products Co. · Nov 1977
K791718 · SEARS 5 FOOT ACRYLIC BATHTUB/WHIRLPOOL
Download PDF Universal-Kundle Corp.