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Critical Measurement Unit

by Bemis Health Care

510(k) K822556

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 NumberK822556 Date18 Oct 1982ClearedStatusActive

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  • Withdrawn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
BYZ
Device Class
Class II
Regulation
21 CFR Part 880.6740
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 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 Critical Measurement Unit is a device classified as a Trap, Sterile Specimen, intended for use in general hospital settings. It is part of a suction canister portfolio designed for collection solutions in various areas of a facility including patient rooms, surgical suites and critical care areas, as well as on portable suction equipment.

The device is supplied as a sterile, single-use product with a capacity of 800 cc. It is authorized under FDA 510(k) clearance K822556 with product code BYZ and was cleared on October 18, 1982. The device is manufactured by Bemis Health Care and is available with various accessories and hardware to accommodate different applications.

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See all devices from Bemis Health Care →

Questions

AI-generated answers, 25 Sep 2026

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

  • What is the Critical Measurement Unit used for?

    The Critical Measurement Unit is a sterile specimen trap designed for collection solutions in various hospital settings including patient rooms, surgical suites, critical care areas, and on portable suction equipment.

  • How is the Critical Measurement Unit supplied?

    The device is supplied as a sterile, single-use product with a capacity of 800 cc and is available with various accessories and hardware to accommodate different applications in healthcare facilities.

  • What is the regulatory status of the Critical Measurement Unit?

    The device is authorized under FDA 510(k) clearance K822556 with product code BYZ and was cleared on October 18, 1982, making it substantially equivalent to other devices in its class.

  • Is the Critical Measurement Unit reusable or single-use?

    The Critical Measurement Unit is supplied as a sterile, single-use product, meaning it should be discarded after one use to maintain sterility and prevent cross-contamination.