Cleared Traditional

K952200 - OMNI-JUG

K952200 is an FDA 510(k) clearance for OMNI-JUG, manufactured by Waterstone Medical, Inc.. The device is a Class 1 General & Plastic Surgery device with product code KDG cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K952200 · Waterstone Medical, Inc. · General & Plastic Surgery device
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Jun 1995
Decision
50d
Days
Class 1
Risk

K952200 is an FDA 510(k) clearance for the OMNI-JUG. Classified as Chisel (osteotome) (product code KDG), Class I - General Controls.

Submitted by Waterstone Medical, Inc. (Bethesda, US). The FDA issued a Cleared decision on June 29, 1995 after a review of 50 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4820 - the FDA general and plastic surgery 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 Waterstone Medical, Inc. devices

FDA 510(k) Submission Details - K952200

510(k) Number K952200 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 1995
Decision Date June 29, 1995
Days to Decision 50 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 115d · This submission: 50d
Pathway characteristics
Predicate-based equivalence.

KDG Device Classification - Class 1, General Controls

Product Code KDG Chisel (osteotome)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4820
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 - KDG Chisel (osteotome)

Devices cleared under the same product code (KDG) and FDA review panel - the closest regulatory comparables to K952200.
SIL-MED WASTE FLUID DUMP BAG
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K780135 · Orthopedic Equipment Co., Inc. · Jan 1978