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Dukal Upst-100

by Dukal LLC

Dukal Upst-100 is a chemical/physical sterilization process indicator (FDA Class II; FDA product code JOJ, Indicator, physical/chemical sterilization process) made by Dukal LLC, cleared under FDA 510(k) K241036 on 17 Dec 2024 and listed in FDA GUDID since 1 Jun 2026 (UDI-DI 10665973032884), 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) K241036

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10665973032884 UDI-DI Date1 Jun 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK241036 Date17 Dec 2024DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K241036 decided 17 Dec 2024 Active
  • FDA GUDID UDI-DI 10665973032884 listed 1 Jun 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K241036
  2. Listed FDA GUDID 10665973032884

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Dukal
Generic name
Chemical/physical sterilization process indicator
Model / Ref / Catalog
UPST-100
Primary DI / UDI-DI
10665973032884
510(k) Number
FDA product code
JOJ
GMDN term
Chemical/physical sterilization process indicator
Device class
Class II
Regulation number
880.2800
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K241036)

Similar devices

Other devices filed under FDA product code JOJ (Indicator, physical/chemical sterilization process).

Other devices from Dukal LLC

See all devices from Dukal LLC →

Properties

  • Single use
  • Over-the-counter
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)