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OmniMed Superior Transducer Protector

by Omni Intl., Inc.

510(k) K851734

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK851734 Date23 May 1985ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
FIB
Device Class
Class II
Regulation
21 CFR Part 876.5820
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The OmniMed Superior Transducer Protector is a dialysis transducer protector classified under regulation number 876.5820. It is a Class II medical device with product code FIB and device name Protector, Transducer, Dialysis, as identified in the 510(k) submission.

It received FDA 510(k) clearance (K851734) on May 23, 1985, as substantially equivalent through a traditional review process. The device is intended for use in gastroenterology and urology settings, and was reviewed by the Gastroenterology-Urology advisory committee. No third-party review was conducted.

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