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Asp Aero-Opa™ 25410

by Advanced Sterilization Products Services Inc.

Asp Aero-Opa™ 25410 is a Class II device made by Advanced Sterilization Products Services Inc., cleared under FDA 510(k) K181472 on 23 Apr 2019 and listed in FDA GUDID since 31 Jul 2019 (UDI-DI 10705037048885), 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) K181472

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 Number10705037048885 UDI-DI Date31 Jul 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK181472 Date23 Apr 2019DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K181472 decided 23 Apr 2019 Active
  • FDA GUDID UDI-DI 10705037048885 listed 31 Jul 2019 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K181472
  2. Listed FDA GUDID 10705037048885

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Asp Aero-Opa™
Generic name
Medical device disinfection agent
Model / Ref / Catalog
25410
Primary DI / UDI-DI
10705037048885
510(k) Number
FDA product code
MED
GMDN term
Medical device disinfection agent
Device class
Class II
Regulation number
880.6885
GUDID distribution status
In Commercial Distribution

Related devices

Category: Medical device disinfection agent

Cleared under the same submission (K181472)

and 8 more cleared under K181472

Similar devices in this category

Other devices filed under Medical device disinfection agent.

Other devices from Advanced Sterilization Products, Inc.

See all devices from Advanced Sterilization Products, Inc. →

Properties

  • Over-the-counter
  • Lot / batch number
  • Expiration date
Other properties (12, all answered No)