autoLog® ATLG

by Medtronic, Inc.

autoLog ATLG is a medical device (FDA Class II; FDA product code CAC, Apparatus, Autotransfusion) made by Medtronic, Inc., cleared under FDA 510(k) K093535 on 22 Mar 2010 and listed in FDA GUDID since 9 Jun 2015 (UDI-DI 00643169266490), 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

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	Number00643169266490 UDI-DI	Date9 Jun 2015Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK093535	Date22 Mar 2010Decided	StatusActive

Official records

AccessGUDID record UDI-DI 00643169266490
FDA 510(k) database 510(k) number K093535

Across registries

2 registries list this device

FDA 510(k) K093535 decided 22 Mar 2010 Active
FDA GUDID UDI-DI 00643169266490 listed 9 Jun 2015 Listed

Timeline

2 dated events

22 Mar 2010 Cleared FDA 510(k) K093535
9 Jun 2015 Listed FDA GUDID 00643169266490

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: autoLog®
Generic name: Autotransfusion system blood component processing set
Model / reference: ATLG

Primary DI / UDI-DI: 00643169266490
510(k) Number: K093535
FDA product code: CAC
GMDN term: Autotransfusion system blood component processing set

Device class: Class II
Regulation number: 868.5830
GUDID distribution status: In Commercial Distribution

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Properties

Prescription use
Serial number

Other properties (13, all answered No)