Aeon CPKit APA-15

by Aeon Biotherapeutics Corp.

Aeon CPKit APA-15 is a Class II device made by Aeon Biotherapeutics Corp., listed under FDA premarket submission BK190393 and listed in FDA GUDID since 9 Nov 2022 (UDI-DI 04719875912009), 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) BK190393

FDA submission, from GUDID

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number04719875912009 UDI-DI	Date9 Nov 2022Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k) from GUDID	NumberBK190393	Date—	StatusActive

Official records

AccessGUDID record UDI-DI 04719875912009

Across registries

2 registries list this device

FDA premarket submission BK190393 Active
FDA GUDID UDI-DI 04719875912009 listed 9 Nov 2022 Listed

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Aeon CPKit
Generic name: Haematological concentrate system preparation kit, platelet concentration
Model / reference: APA-15

Primary DI / UDI-DI: 04719875912009
FDA product code: ORG
GMDN term: Haematological concentrate system preparation kit, platelet concentration

Device class: Class II
Regulation number: 864.9245
GUDID distribution status: In Commercial Distribution

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Properties

Supplied sterile
Single use
Lot / batch number
Expiration date

Other properties (11, all answered No)