M.blue FX805T

M.blue FX805T is a Class II device made by Aesculap AG, cleared under FDA 510(k) K192266 on 21 Nov 2019 and listed in FDA GUDID since 4 Mar 2020 (UDI-DI 04041906504434), 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	Number04041906504434 UDI-DI	Date4 Mar 2020Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK192266	Date21 Nov 2019Decided	StatusActive

Official records

AccessGUDID record UDI-DI 04041906504434
FDA 510(k) database 510(k) number K192266

Across registries

2 registries list this device

FDA 510(k) K192266 decided 21 Nov 2019 Active
FDA GUDID UDI-DI 04041906504434 listed 4 Mar 2020 Listed

Timeline

2 dated events

21 Nov 2019 Cleared FDA 510(k) K192266
4 Mar 2020 Listed FDA GUDID 04041906504434

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: M.blue
Generic name: Cerebrospinal fluid shunt valve
Model / Ref / Catalog: FX805T

Primary DI / UDI-DI: 04041906504434
510(k) Number: K192266
FDA product code: JXG
GMDN term: Cerebrospinal fluid shunt valve

Device class: Class II
Regulation number: 882.5550
GUDID distribution status: In Commercial Distribution

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Properties

Supplied sterile
Single use
Implantable
Prescription use
Serial number
Expiration date

Other properties (9, all answered No)