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A5 Anesthesia Delivery System

by Datascope Corp., Patient Monitoring Division

510(k) K123211

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 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 · Abbreviated NumberK123211 Date14 Feb 2013ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0846-2018 FDA Class II initiated 14 Jul 2017

    A software issue may result in the previous settings being applied instead of the default settings or the unit may skip the startup leak test.

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  • Withdrawn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
BSZ
Device Class
Class II
Regulation
21 CFR Part 868.5160
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

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