Iob Iob-030

by Iob Medical, Inc.

Iob Iob-030 is a Class II device made by Iob Medical, Inc., cleared under FDA 510(k) K190221 on 25 Oct 2019 and listed in FDA GUDID since 8 Mar 2022 (UDI-DI 00850035767306), 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	Number00850035767306 UDI-DI	Date8 Mar 2022Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK190221	Date25 Oct 2019Decided	StatusActive

Official records

AccessGUDID record UDI-DI 00850035767306
FDA 510(k) database 510(k) number K190221

Across registries

2 registries list this device

FDA 510(k) K190221 decided 25 Oct 2019 Active
FDA GUDID UDI-DI 00850035767306 listed 8 Mar 2022 Listed

Timeline

2 dated events

25 Oct 2019 Cleared FDA 510(k) K190221
8 Mar 2022 Listed FDA GUDID 00850035767306

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Iob
Generic name: Circulating-air whole-body heating system control unit
Model / reference: IOB-030

Primary DI / UDI-DI: 00850035767306
510(k) Number: K190221
FDA product code: DWJ
GMDN term: Circulating-air whole-body heating system control unit

Device class: Class II
Regulation number: 870.5900
GUDID distribution status: In Commercial Distribution

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Properties

Single use
Lot / batch number
Expiration date

Other properties (12, all answered No)