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Navigator Anesthesia Delivery System, Model 0998-00-3024-01

by Datascope Corp., Patient Monitoring Division

510(k) K080175

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 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 NumberK080175 Date9 Jun 2008ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-1313-2010 FDA Unclassified (pre-2012) initiated 5 Mar 2010

    An issue affecting the caster mount on the AS3000 System have been identified, specifically reports of the caster mount breaking, causing the wheel to fall off and the unit to tip.

    • Terminated Z-0319-2009 FDA Unclassified (pre-2012) initiated 7 Oct 2008

    Two issues have been identified with the AS3000 unit. 1. The threadlocker of the caster (wheels) may not have been utilized, which may allow the caster to loosen and possibly separate from the unit. 2. The use of select brands of pre-pack absorber in the absorber canister of the AS3000 has been associated, in some cases, with gas leakage around the pre-pack, rather than through the absorber mate

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  • Withdrawn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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