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Vital Sync VITALSYNCSW03

by Covidien LP 9 variants

Vital Sync VITALSYNCSW03 is a Class II device made by Covidien LP, cleared under FDA 510(k) K160718 on 14 Nov 2016 and listed in FDA GUDID since 25 Oct 2026 (UDI-DI 10884521861114), active as of 9 Nov 2026.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

Recall on shared 510(k) K160718; other models may be affected

Documents

510(k) K160718

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 9 Nov 2026.

Regulatory status

as of registry sync 9 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10884521861114 UDI-DI Date25 Oct 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK160718 Date14 Nov 2016DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K160718 decided 14 Nov 2016 Active
  • FDA GUDID UDI-DI 10884521861114 listed 25 Oct 2026 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1557-2026 FDA Class II initiated 30 Jan 2026 on shared 510(k) K160718

    Due to complaints and investigations stating that alarms from the primary patient bedside monitor was not alarming/being transmitted and received on the remote patient monitoring system.

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

Timeline

3 dated events

  1. Cleared FDA 510(k) K160718
  2. Recall initiated FDA recalls Z-1557-2026
  3. Listed FDA GUDID 10884521861114

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Vital Sync
Generic name
Multiparameter physiologic analysis workstation
Model / reference
VITALSYNCSW03
Primary DI / UDI-DI
10884521861114
510(k) Number
FDA product code
DRG
GMDN term
Multiparameter physiologic analysis workstation
Device class
Class II
Regulation number
870.2910
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K160718)

and 8 more cleared under K160718

Other devices from Covidien LP

  • LigaSure MRASILF19

    Class II

  • Shiley 110860

    Class II

  • Shiley 110865

    Class II

  • Shiley 110870

    Class II

See all devices from Covidien LP →

Properties

  • Prescription use
  • Lot / batch number
Other properties (13, all answered No)