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Xltek 011291

by Embla Systems

Xltek 011291 is a Class II device made by Embla Systems, cleared under FDA 510(k) K122516 on 21 Feb 2013 and listed in FDA GUDID since 25 Oct 2016 (UDI-DI 00382830024662), active as of 23 Oct 2026.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K122516

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 Number00382830024662 UDI-DI Date25 Oct 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK122516 Date21 Feb 2013DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K122516 decided 21 Feb 2013 Active
  • FDA GUDID UDI-DI 00382830024662 listed 25 Oct 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K122516
  2. Listed FDA GUDID 00382830024662

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Xltek
Generic name
Multiple physiological signal amplifier
Model / reference
011291
Primary DI / UDI-DI
00382830024662
510(k) Number
FDA product code
MNR
GMDN term
Multiple physiological signal amplifier
Device class
Class II
Regulation number
868.2375
GUDID distribution status
In Commercial Distribution

Related devices

Category: Multiple physiological signal amplifier

Cleared under the same submission (K122516)

Similar devices

Other devices filed under FDA product code MNR (Ventilatory Effort Recorder).

Other devices from Embla Systems

See all devices from Embla Systems →

Properties

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