Cleared Traditional

K923942 - RHOMBO MEDICAL RHOMBO-FILL

K923942 is an FDA 510(k) clearance for RHOMBO MEDICAL RHOMBO-FILL, manufactured by International Medical Products, Inc.. The device is a Class 1 Physical Medicine device with product code KNN cleared through the Traditional 510(k) pathway after a 231-day FDA review.

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

FDA 510(k) Submission Details - K923942

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.

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 K923942.
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