Cleared Traditional

K830425 - TOILET SEAT RAISED

K830425 is an FDA 510(k) clearance for TOILET SEAT RAISED, manufactured by Maddak, Inc.. The device is a Class 1 Physical Medicine device with product code ILS cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K830425 · Maddak, Inc. · Physical Medicine device
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May 1983
Decision
89d
Days
Class 1
Risk

K830425 is an FDA 510(k) clearance for the TOILET SEAT RAISED. Classified as Adaptor, Hygiene (product code ILS), Class I - General Controls.

Submitted by Maddak, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 9, 1983 after a review of 89 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 Maddak, Inc. devices

FDA 510(k) Submission Details - K830425

510(k) Number K830425 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 1983
Decision Date May 09, 1983
Days to Decision 89 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
26d faster than avg
Panel avg: 115d · This submission: 89d
Pathway characteristics
Predicate-based equivalence.

ILS Device Classification - Class 1, General Controls

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 21
Devices cleared under the same product code (ILS) and FDA review panel - the closest regulatory comparables to K830425.
LAVATORY SEAT HEIGHTENER
K830853 · Lic-Orthion · Jun 1983
RAISED TOILET SEATS & NAIL CLIPPERS
K831547 · Fred Sammons, Inc. · Jun 1983
SHOWER STOOL W/HANDLES
K830852 · Lic-Orthion · Apr 1983
BATHING CHAIR FOR CHILD
K823641 · Fred Sammons, Inc. · Jan 1983
DISPOSABLE TOOTH BRUSH
K823626 · Fred Sammons, Inc. · Dec 1982
PLASTIC BREAK RESISTANT MIRROR
K823606 · Fred Sammons, Inc. · Dec 1982