Cleared Traditional

K810883 - OMED SILICONE INSTRUMENT COVERS

K810883 is an FDA 510(k) clearance for OMED SILICONE INSTRUMENT COVERS, manufactured by Omega-Med Intl., Inc.. The device is a Class 1 General & Plastic Surgery device with product code KDC cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K810883 · Omega-Med Intl., Inc. · General & Plastic Surgery device
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Apr 1981
Decision
22d
Days
Class 1
Risk

K810883 is an FDA 510(k) clearance for the OMED SILICONE INSTRUMENT COVERS. Classified as Instrument, Surgical, Disposable (product code KDC), Class I - General Controls.

Submitted by Omega-Med Intl., Inc. (Mchenry, US). The FDA issued a Cleared decision on April 23, 1981 after a review of 22 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - 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 Omega-Med Intl., Inc. devices

FDA 510(k) Submission Details - K810883

510(k) Number K810883 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 1981
Decision Date April 23, 1981
Days to Decision 22 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 115d · This submission: 22d
Pathway characteristics
Predicate-based equivalence.

KDC Device Classification - Class 1, General Controls

Product Code KDC Instrument, Surgical, Disposable
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
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 - KDC Instrument, Surgical, Disposable

All 32
Devices cleared under the same product code (KDC) and FDA review panel - the closest regulatory comparables to K810883.
FLEX-TEMPLATE
K811280 · Mick Radio-Nuclear Instruments, Inc. · Jun 1981
DAVIS & GECK NEEDLE/SHARPS COUNTER
K811191 · Davis & Geck, Inc. · May 1981
SURGICAL STAPLE REMOVER
K811120 · Acme United Corp. · May 1981
VASCULAR TIE (VAS-TIE)
K810080 · Sil-Med Corp. · Apr 1981
SEARLE VASCULAR LOOPS
K802485 · G.D. Searle and Co. · Feb 1981
SWR DISPOSABLE PREP RAZOR
K810112 · G.D. Searle and Co. · Feb 1981