Cleared Traditional

RHOMBO MEDICAL RHOMBO-FILL (K923942) - FDA 510(k) Clearance

Class I Physical Medicine device.

K923942 · International Medical Products, Inc. · Physical Medicine device
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Mar 1993
Decision
231d
Days
Class 1
Risk

K923942 is an FDA 510(k) clearance for the RHOMBO MEDICAL RHOMBO-FILL. Classified as Components, Wheelchair (product code KNN), Class I - General Controls.

Submitted by International Medical Products, Inc. (Minneapolis, US). The FDA issued a Cleared decision on March 24, 1993 after a review of 231 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all International Medical Products, Inc. devices

Submission Details

510(k) Number K923942 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 1992
Decision Date March 24, 1993
Days to Decision 231 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
116d slower than avg
Panel avg: 115d · This submission: 231d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 7
Devices cleared under the same product code (KNN) and FDA review panel - the closest regulatory comparables to K923942.
KISS Dynamic Back Support, KISS Dynamic Solid Drop Seat
K211919 · Kinetic Innovative Seating System, LLC · Mar 2022
CUSHION, WHELCHAR AND FLOTATION
K915629 · Invacare Corp. · Jan 1992
(ROTH)SPIRAL ROTATING PROSTATIC BIOPSY NEEDLE
K863385 · Cook Urological, Inc. · Nov 1986
ARM THROUGH FOR WHEELCHAIR BK-6458-01
K823637 · Fred Sammons, Inc. · Jan 1983
ARM THROUGH FOR WHEELCHAIR BK 6454-01 &
K823638 · Fred Sammons, Inc. · Jan 1983
BK-6470 ADJUSTABLE ELEVATING WHEELCHAIR
K813636 · Fred Sammons, Inc. · Jan 1982