Cleared Traditional

K961562 - OSTEOMARK

K961562 is an FDA 510(k) clearance for OSTEOMARK, manufactured by Ostex Intl., Inc.. The device is a Class 1 Chemistry device with product code JMM cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K961562 · Ostex Intl., Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1996
Decision
80d
Days
Class 1
Risk

K961562 is an FDA 510(k) clearance for the OSTEOMARK. Classified as Column Chromatography & Color Development, Hydroxyproline (product code JMM), Class I - General Controls.

Submitted by Ostex Intl., Inc. (Seattle, US). The FDA issued a Cleared decision on July 11, 1996 after a review of 80 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1400 - the FDA in vitro diagnostics and chemistry 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 Ostex Intl., Inc. devices

FDA 510(k) Submission Details - K961562

510(k) Number K961562 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 1996
Decision Date July 11, 1996
Days to Decision 80 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 88d · This submission: 80d
Pathway characteristics
Predicate-based equivalence.

JMM Device Classification - Class 1, General Controls

Product Code JMM Column Chromatography & Color Development, Hydroxyproline
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1400
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 - JMM Column Chromatography & Color Development, Hydroxyproline

All 15
Devices cleared under the same product code (JMM) and FDA review panel - the closest regulatory comparables to K961562.
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K770603 · Organon, Inc. · Sep 1977