Unipack UPST-075

by Unipack Medical Corporation

Unipack UPST-075 is a Class II device made by Unipack Medical Corporation, cleared under FDA 510(k) K993764 on 16 Dec 1999 and listed in FDA GUDID since 6 Dec 2022 (UDI-DI D784UPST0751), 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	NumberD784UPST0751 UDI-DI	Date6 Dec 2022Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK993764	Date16 Dec 1999Decided	StatusActive

Official records

FDA 510(k) database 510(k) number K993764

Across registries

2 registries list this device

FDA 510(k) K993764 decided 16 Dec 1999 Active
FDA GUDID UDI-DI D784UPST0751 listed 6 Dec 2022 Listed

Timeline

2 dated events

16 Dec 1999 Cleared FDA 510(k) K993764
6 Dec 2022 Listed FDA GUDID D784UPST0751

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Unipack
Generic name: Chemical/physical sterilization process indicator
Model / Ref / Catalog: UPST-075

Primary DI / UDI-DI: D784UPST0751
510(k) Number: K993764
FDA product code: KCT
GMDN term: Chemical/physical sterilization process indicator

Device class: Class II
Regulation number: 880.6850
GUDID distribution status: In Commercial Distribution

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Properties

Single use
Over-the-counter
Lot / batch number
Expiration date

Other properties (11, all answered No)