103164 tCOM+

103164 tCOM+ is a Class II device made by SenTec AG, cleared under FDA 510(k) K232516 on 17 May 2024 and listed in FDA GUDID since 5 Jul 2024 (UDI-DI 07640121880995), active as of 12 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

None found

in data synced 12 Nov 2026

Documents

FDA submission, from GUDID

Trust

Source GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number07640121880995 UDI-DI	Date5 Jul 2024Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK232516	Date17 May 2024Decided	StatusActive

Official records

AccessGUDID record UDI-DI 07640121880995
FDA 510(k) database 510(k) number K232516

Across registries

2 registries list this device

FDA 510(k) K232516 decided 17 May 2024 Active
FDA GUDID UDI-DI 07640121880995 listed 5 Jul 2024 Listed

Timeline

2 dated events

17 May 2024 Cleared FDA 510(k) K232516
5 Jul 2024 Listed FDA GUDID 07640121880995

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Generic name: Transcutaneous blood gas monitoring system
Model / reference: 103164

Primary DI / UDI-DI: 07640121880995
510(k) Number: K232516
FDA product code: DPZ, DQA, KLK, LKD, LPP
GMDN term: Transcutaneous blood gas monitoring system

Device class: Class II
Regulation number: 870.2710, 870.2700, 868.2500, 868.2480
GUDID distribution status: In Commercial Distribution

MRI safety: MR Unsafe

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Other devices from SenTec AG

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Properties

Prescription use
Serial number

Other properties (13, all answered No)