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Med-Plastics Intl., Inc. Breathing Filter

by Med-Plastics Intl., Inc.

510(k) K930760

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK930760 Date11 Mar 1993ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 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  • Withdrawn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
CAH
Device Class
Class II
Regulation
21 CFR Part 868.5260
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

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

The device is a Filter, Bacterial, Breathing-Circuit, classified under product code CAH and regulation number 868.5260. It is a Class II medical device with special controls, as determined by FDA 510(k) clearance K930760, granted on March 11, 1993, and found substantially equivalent to a predicate device.

It is intended for use in anesthesiology settings. The device is supplied as a single-use, non-sterile breathing circuit filter. No information regarding MRI safety, sizes, storage conditions, or reusability is provided in the data.

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