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Trackit Sleepwalker MK3 + SaO2 + BT

by Lifelines Limited

Trackit Sleepwalker MK3 + SaO2 + BT (1304) is a Class II device made by Lifelines Limited, cleared under FDA 510(k) K010460 on 14 May 2001 and listed in FDA GUDID since 18 Jan 2019 (UDI-DI 05060275450158), active (FDA 510(k)), not in commercial distribution (GUDID) as of 22 Oct 2026.

Active United States. Also listed in GUDID (US), not in commercial distribution.

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K010460

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number05060275450158 UDI-DI Date18 Jan 2019ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k) from GUDID NumberK010460 Date14 May 2001IssuedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K010460 decided 14 May 2001 Active
  • FDA GUDID UDI-DI 05060275450158 listed 18 Jan 2019 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K010460
  2. Listed FDA GUDID 05060275450158

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Trackit Sleepwalker
Generic name
Polysomnograph
Model / Ref / Catalog
MK3 + SaO2 + BT, 1304
Primary DI / UDI-DI
05060275450158
510(k) Number
FDA product code
OLV
GMDN term
Polysomnograph
Device class
Class II
Regulation number
882.1400
GUDID distribution status
Not in Commercial Distribution

Related devices

Category: Polysomnograph

Similar devices in this category

Other devices filed under Polysomnograph.

Other devices from Lifelines Limited

Properties

  • Prescription use
  • Serial number
Other properties (13, all answered No)