Cleared Traditional

K852049 - MEDICAL TOILET SEAT

K852049 is an FDA 510(k) clearance for MEDICAL TOILET SEAT, manufactured by Pedro Aleman. The device is a Class 1 Physical Medicine device with product code ILS cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K852049 · Pedro Aleman · Physical Medicine device
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Jun 1985
Decision
47d
Days
Class 1
Risk

K852049 is an FDA 510(k) clearance for the MEDICAL TOILET SEAT. Classified as Adaptor, Hygiene (product code ILS), Class I - General Controls.

Submitted by Pedro Aleman (D.F. Mexico, MX). The FDA issued a Cleared decision on June 24, 1985 after a review of 47 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 Pedro Aleman devices

FDA 510(k) Submission Details - K852049

510(k) Number K852049 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 1985
Decision Date June 24, 1985
Days to Decision 47 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
68d faster than avg
Panel avg: 115d · This submission: 47d
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 22
Devices cleared under the same product code (ILS) and FDA review panel - the closest regulatory comparables to K852049.
LAVATORY SEAT HEIGHTENER
K830853 · Lic-Orthion · Jun 1983
RAISED TOILET SEATS & NAIL CLIPPERS
K831547 · Fred Sammons, Inc. · Jun 1983
TOILET SEAT RAISED
K830425 · Maddak, Inc. · May 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