Cleared Traditional

TUBMATE (K811301) - FDA 510(k) Clearance

Class I Physical Medicine device.

K811301 · American Stair-Glide Corp. · Physical Medicine device
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May 1981
Decision
16d
Days
Class 1
Risk

K811301 is an FDA 510(k) clearance for the TUBMATE. Classified as Adaptor, Hygiene (product code ILS), Class I - General Controls.

Submitted by American Stair-Glide Corp. (Mchenry, US). The FDA issued a Cleared decision on May 27, 1981 after a review of 16 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 American Stair-Glide Corp. devices

Submission Details

510(k) Number K811301 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 1981
Decision Date May 27, 1981
Days to Decision 16 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
99d faster than avg
Panel avg: 115d · This submission: 16d
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 30
Devices cleared under the same product code (ILS) and FDA review panel - the closest regulatory comparables to K811301.
RAISED TOILET SEATS & NAIL CLIPPERS
K831547 · Fred Sammons, Inc. · Jun 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
BK-6477 THE DERBY RAISED TOILET SEAT
K821860 · Fred Sammons, Inc. · Jul 1982
HYGIENE ADAPTORS
K821638 · Fred Sammons, Inc. · Jun 1982