Cleared Traditional

K821009 - BATHTUB GRAB BAR

K821009 is the FDA 510(k) clearance for BATHTUB GRAB BAR by Guardian Products Co., Inc.. It is a Class 1 Physical Medicine device (product code ILS) cleared through the Traditional 510(k) pathway after a 9-day FDA review.

K821009 · Guardian Products Co., Inc. · Physical Medicine device
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Apr 1982
Decision
9d
Days
Class 1
Risk

K821009 is an FDA 510(k) clearance for the BATHTUB GRAB BAR. Classified as Adaptor, Hygiene (product code ILS), Class I - General Controls.

Submitted by Guardian Products Co., Inc. (Mchenry, US). The FDA issued a Cleared decision on April 21, 1982 after a review of 9 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 Guardian Products Co., Inc. devices

Submission Details

510(k) Number K821009 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 1982
Decision Date April 21, 1982
Days to Decision 9 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
106d faster than avg
Panel avg: 115d · This submission: 9d
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 K821009.
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
CHILDS TOILET TRAINER HYGIENE AIDS
K813635 · Fred Sammons, Inc. · Jan 1982
HYGIENE ADAPTORS
K812352 · Fred Sammons, Inc. · Sep 1981
SECURA BATH SEAT
K812483 · Maddak, Inc. · Sep 1981