Cleared Traditional

K821903 - DISC-O-AID

K821903 is an FDA 510(k) clearance for DISC-O-AID, manufactured by M. Dahm International Aps. The device is a Class 1 Physical Medicine device with product code IKX cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K821903 · M. Dahm International Aps · Physical Medicine device
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Jul 1982
Decision
22d
Days
Class 1
Risk

K821903 is an FDA 510(k) clearance for the DISC-O-AID. Classified as Aid, Transfer (product code IKX), Class I - General Controls.

Submitted by M. Dahm International Aps (Mchenry, US). The FDA issued a Cleared decision on July 20, 1982 after a review of 22 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.

FDA 510(k) Submission Details - K821903

510(k) Number K821903 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 1982
Decision Date July 20, 1982
Days to Decision 22 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
94d faster than avg
Panel avg: 116d · This submission: 22d
Pathway characteristics
Predicate-based equivalence.

IKX Device Classification - Class 1, General Controls

Product Code IKX Aid, Transfer
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 - IKX Aid, Transfer

All 16
Devices cleared under the same product code (IKX) and FDA review panel - the closest regulatory comparables to K821903.
CHAIR OR BED LEG EXTENDERS
K823634 · Fred Sammons, Inc. · Dec 1982
BATH TUB SEAT & BATH BOARD
K823153 · Orthion Corp. · Nov 1982
SHOWER STOOL W/HANDLES
K823154 · Orthion Corp. · Nov 1982
BATHTUB TRANSFER BENCH
K821010 · Guardian Products Co., Inc. · Apr 1982
BK-6111 HI-D TRANSFER BOARD
K813629 · Fred Sammons, Inc. · Jan 1982
TRANSFER BENCH
K812475 · Maddak, Inc. · Sep 1981
K821903 · DISC-O-AID
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