Cleared Traditional

K791423 - TOILET TRAINER FOR HANDICAPPED CHILD

K791423 is the FDA 510(k) clearance for TOILET TRAINER FOR HANDICAPPED CHILD by Kaye Products, Inc.. It is a Class 1 Physical Medicine device (product code ILS) cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K791423 · Kaye Products, Inc. · Physical Medicine device
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Aug 1979
Decision
10d
Days
Class 1
Risk

K791423 is an FDA 510(k) clearance for the TOILET TRAINER FOR HANDICAPPED CHILD. Classified as Adaptor, Hygiene (product code ILS), Class I - General Controls.

Submitted by Kaye Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 10, 1979 after a review of 10 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5050 - 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 Kaye Products, Inc. devices

Submission Details

510(k) Number K791423 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 1979
Decision Date August 10, 1979
Days to Decision 10 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
105d faster than avg
Panel avg: 115d · This submission: 10d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code ILS Adaptor, Hygiene
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5050
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - ILS Adaptor, Hygiene

All 20
Devices cleared under the same product code (ILS) and FDA review panel - the closest regulatory comparables to K791423.
HYGIENE ADAPTORS
K812352 · Fred Sammons, Inc. · Sep 1981
SECURA BATH SEAT
K812483 · Maddak, Inc. · Sep 1981
HYGIENE ADAPTORS
K810456 · Fred Sammons, Inc. · Mar 1981
ANUS STIMULATOR
K790531 · Maddak, Inc. · Apr 1979
SEMI-RECLINING BATH CHARI & BELT
K790175 · Fred Sammons, Inc. · Feb 1979
WATER POWERED BATH CHAIR LIFT
K790178 · Fred Sammons, Inc. · Feb 1979