CytoTherm CT-D1

by Cytotherm LP

CytoTherm CT-D1 is a Class II device made by Cytotherm LP, listed under FDA premarket submission BK080019 and listed in FDA GUDID since 1 Sep 2016 (UDI-DI 00861128000354), active as of 22 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 22 Oct 2026

Documents

510(k) BK080019

FDA submission, from GUDID

Trust

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00861128000354 UDI-DI	Date1 Sep 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k) from GUDID	NumberBK080019	Date—	StatusActive

Official records

AccessGUDID record UDI-DI 00861128000354

Across registries

2 registries list this device

FDA premarket submission BK080019 Active
FDA GUDID UDI-DI 00861128000354 listed 1 Sep 2016 Listed

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: CytoTherm
Generic name: Cryopreserved blood/tissue thawing unit
Model / reference: CT-D1

Primary DI / UDI-DI: 00861128000354
FDA product code: KZL
GMDN term: Cryopreserved blood/tissue thawing unit

Device class: Class II
Regulation number: 864.9205
GUDID distribution status: In Commercial Distribution

Other devices from Cytotherm LP

CytoTherm CT-4S

Class II
CytoTherm CT-4T.6C

Class II
CytoTherm CT-4T

Class II
CytoTherm CT-DR

Class II

See all devices from Cytotherm LP →

Properties

Serial number

Other properties (14, all answered No)