Cleared Traditional

K921369 - BIOMEDICAL HORIZONS MODEL 1001

K921369 is an FDA 510(k) clearance for BIOMEDICAL HORIZONS MODEL 1001, manufactured by Biomedical Horizons, Inc.. The device is a Class 1 Physical Medicine device with product code KNN cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K921369 · Biomedical Horizons, Inc. · Physical Medicine device
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May 1992
Decision
52d
Days
Class 1
Risk

K921369 is an FDA 510(k) clearance for the BIOMEDICAL HORIZONS MODEL 1001. Classified as Components, Wheelchair (product code KNN), Class I - General Controls.

Submitted by Biomedical Horizons, Inc. (Jackson, US). The FDA issued a Cleared decision on May 11, 1992 after a review of 52 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3920 - 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 Biomedical Horizons, Inc. devices

FDA 510(k) Submission Details - K921369

510(k) Number K921369 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 1992
Decision Date May 11, 1992
Days to Decision 52 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 115d · This submission: 52d
Pathway characteristics
Predicate-based equivalence.

KNN Device Classification - Class 1, General Controls

Product Code KNN Components, Wheelchair
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3920
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 - KNN Components, Wheelchair

All 12
Devices cleared under the same product code (KNN) and FDA review panel - the closest regulatory comparables to K921369.
KISS Dynamic Back Support, KISS Dynamic Solid Drop Seat
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CUSHION, WHELCHAR AND FLOTATION
K915629 · Invacare Corp. · Jan 1992
LIFESTYLE SOF. CARE GEL CHAIR CUSHION
K882012 · Gaymar Industries, Inc. · May 1988
VAN-TEC PROSTATE BIOPSY NEEDLE
K870698 · Van-Tec, Inc. · Mar 1987
(ROTH)SPIRAL ROTATING PROSTATIC BIOPSY NEEDLE
K863385 · Cook Urological, Inc. · Nov 1986
WHEELCHAIR ACCESSORIES
K840629 · Poirier S.A. · Feb 1984