Cleared Traditional

K870300 - BELMONT, PODIATRY X-RAY - REMEX, MODEL PD75

K870300 is an FDA 510(k) clearance for BELMONT, manufactured by Belmont Equipment Corp.. The device is a Class 2 Radiology device with product code KPR cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K870300 · Belmont Equipment Corp. · Radiology device
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Mar 1987
Decision
56d
Days
Class 2
Risk

K870300 is an FDA 510(k) clearance for the BELMONT, PODIATRY X-RAY - REMEX, MODEL PD75. Classified as System, X-ray, Stationary (product code KPR), Class II - Special Controls.

Submitted by Belmont Equipment Corp. (Somerset, US). The FDA issued a Cleared decision on March 25, 1987 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1680 - the FDA radiology and imaging software oversight 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 - K870300

510(k) Number K870300 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 1987
Decision Date March 25, 1987
Days to Decision 56 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 107d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPR Device Classification - Class 2, Special Controls

Product Code KPR System, X-ray, Stationary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1680
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - KPR System, X-ray, Stationary

All 347
Devices cleared under the same product code (KPR) and FDA review panel - the closest regulatory comparables to K870300.
BC 1800 FINGER POSITIONER
K872317 · Instrumentation Industries, Inc. · Aug 1987
JOVI MYELOGRAPHY HARNESS
K872468 · Jovi, Inc. · Jul 1987
SCX INFORMATION MANAGEMENT SYSTEM
K870400 · General Electric Co. · Jun 1987
REFURBISH DIAGNOSTIC X-RAY EQUIPMENT
K863309 · Chemarts and Assoc., Inc. · Jan 1987
AMBER-CHEST
K862616 · Old Delft Corp. of America · Sep 1986
MODEL RS-3I RADIOGRAPHIC/FLUROSCOPIC X-RAY SYSTEM
K861994 · Medicor USA , Ltd. · Jul 1986
K870300 · BELMONT, PODIATRY X-RAY - REMEX, MODEL PD75
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