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Cobe Disposable Pressure Transducer

by Cobe Laboratories, Inc.

510(k) K810637

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

5 closed

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 NumberK810637 Date23 Apr 1981ClearedStatusActive

Recalls

5 recalls · FDA

  • 5 recalls, same reason

    • Terminated Z-0296-2020 FDA Class II initiated 16 Oct 2018
    • Terminated Z-0291-2020 FDA Class II initiated 16 Oct 2018
    • Terminated Z-0289-2020 FDA Class II initiated 16 Oct 2018
    • Terminated Z-0288-2020 FDA Class II initiated 16 Oct 2018
    • Terminated Z-0292-2020 FDA Class II initiated 16 Oct 2018

    The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product.

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  • Withdrawn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
DRS
Device Class
Class II
Regulation
21 CFR Part 870.2850
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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