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OPC OXYGEN CONSERVING REGULATOR - Opc-830

by Western Ent.

510(k) K010747

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

3 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 11 Oct 2026. What this means

Regulatory status

as of registry sync 11 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK010747 Date16 May 2001ClearedStatusActive

Recalls

3 recalls · FDA

  • 3 recalls, same reason

    • Terminated Z-0056-04 FDA Unclassified (pre-2012) initiated 2 Oct 2003 on shared 510(k) K010747
    • Terminated Z-0055-04 FDA Unclassified (pre-2012) initiated 2 Oct 2003 on shared 510(k) K010747
    • Terminated Z-0054-04 FDA Unclassified (pre-2012) initiated 2 Oct 2003 on shared 510(k) K010747

    The demand valve is defective and does not function as intended in the 'Conservative Mode'.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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
NFB
Models / Variants
Opc-830
Device Class
Class II
Regulation
21 CFR Part 868.5905
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent