Cleared Traditional

HYGIENE ADAPTORS (K812352) - FDA 510(k) Clearance

Class I Physical Medicine device.

K812352 · Fred Sammons, Inc. · Physical Medicine device
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Sep 1981
Decision
27d
Days
Class 1
Risk

K812352 is an FDA 510(k) clearance for the HYGIENE ADAPTORS. Classified as Adaptor, Hygiene (product code ILS), Class I - General Controls.

Submitted by Fred Sammons, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 14, 1981 after a review of 27 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 Fred Sammons, Inc. devices

Submission Details

510(k) Number K812352 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 1981
Decision Date September 14, 1981
Days to Decision 27 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
88d faster than avg
Panel avg: 115d · This submission: 27d
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 16
Devices cleared under the same product code (ILS) and FDA review panel - the closest regulatory comparables to K812352.
BK-6477 THE DERBY RAISED TOILET SEAT
K821860 · Fred Sammons, Inc. · Jul 1982
HYGIENE ADAPTORS
K821638 · Fred Sammons, Inc. · Jun 1982
CHILDS TOILET TRAINER HYGIENE AIDS
K813635 · Fred Sammons, Inc. · Jan 1982
HYGIENE ADAPTORS
K810456 · Fred Sammons, Inc. · Mar 1981
SEMI-RECLINING BATH CHARI & BELT
K790175 · Fred Sammons, Inc. · Feb 1979
WATER POWERED BATH CHAIR LIFT
K790178 · Fred Sammons, Inc. · Feb 1979