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Trulink NIBP Hoses and adapters

by Spacelabs Healthcare (Washington), Inc 29 variants

Trulink NIBP Hoses and adapters (162-0046-01) is a Class II device made by Spacelabs Healthcare (Washington), Inc, cleared under FDA 510(k) K112173 on 5 Oct 2011 and listed in FDA GUDID since 22 Apr 2024 (UDI-DI 10841522127366), active as of 23 Oct 2026. One FDA recall is linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

510(k) K112173

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10841522127366 UDI-DI Date22 Apr 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK112173 Date5 Oct 2011DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K112173 decided 5 Oct 2011 Active
  • FDA GUDID UDI-DI 10841522127366 listed 22 Apr 2024 Listed

Recalls

1 recall · FDA

    • Terminated Z-2077-2014 FDA Class II initiated 18 Jun 2014

    With this software version, the Minimum Alveolar Concentration (MAC) value displayed is extremely high (20.1) and physiologically invalid.

Timeline

3 dated events

  1. Cleared FDA 510(k) K112173
  2. Recall initiated FDA recalls Z-2077-2014
  3. Listed FDA GUDID 10841522127366

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Trulink
Generic name
Patient monitoring system module, multiple-gas
Model / Ref / Catalog
NIBP Hoses and adapters, 162-0046-01
Primary DI / UDI-DI
10841522127366
510(k) Number
FDA product code
CBR
GMDN term
Patient monitoring system module, multiple-gas
Device class
Class II
Regulation number
868.1700
GUDID distribution status
In Commercial Distribution

Related devices

Category: Patient monitoring system module, multiple-gas

Cleared under the same submission (K112173)

and 1 more cleared under K112173

Similar devices

Other devices filed under FDA product code CBR (ANALYZER, GAS, NITROUS-OXIDE, GASEOUS PHASE (ANESTHETIC CONC.)).

Other devices from Spacelabs Healthcare (Washington), Inc

See all devices from Spacelabs Healthcare (Washington), Inc →

Properties

  • Single use
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (9, all answered No)