STERLINK™ Mini-bio

by Plasmapp Co., Ltd.

STERLINK™ Mini-bio is a Class II device made by Plasmapp Co., Ltd., cleared under FDA 510(k) K212193 on 22 Oct 2021 and listed in FDA GUDID since 27 Dec 2021 (UDI-DI 08800066500221), 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

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	Number08800066500221 UDI-DI	Date27 Dec 2021Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK212193	Date22 Oct 2021Decided	StatusActive

Official records

AccessGUDID record UDI-DI 08800066500221
FDA 510(k) database 510(k) number K212193

Across registries

2 registries list this device

FDA 510(k) K212193 decided 22 Oct 2021 Active
FDA GUDID UDI-DI 08800066500221 listed 27 Dec 2021 Listed

Timeline

2 dated events

22 Oct 2021 Cleared FDA 510(k) K212193
27 Dec 2021 Listed FDA GUDID 08800066500221

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Sterlink™
Generic name: Biological sterilization indicator reader
Model / reference: Mini-bio

Primary DI / UDI-DI: 08800066500221
510(k) Number: K212193
FDA product code: FRC, JOJ
GMDN term: Biological sterilization indicator reader

Device class: Class II
Regulation number: 880.2800
GUDID distribution status: In Commercial Distribution

Other devices from Plasmapp Co., Ltd.

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Sterlink™ CT40

Class II

See all devices from Plasmapp Co., Ltd. →

Properties

Over-the-counter
Lot / batch number

Other properties (13, all answered No)