Aerozyme™ Xtra 25520
by Advanced Sterilization Products Services Inc.
Aerozyme™ Xtra 25520 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 16 Dec 2025 (UDI-DI 10705037048755), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number10705037048755 | Date16 Dec 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK181472 | Date23 Apr 2019 | StatusActive |
Official records
- AccessGUDID record 10705037048755
- FDA 510(k) database K181472
Across registries
- FDA 510(k) K181472 decided 23 Apr 2019 Active
- FDA GUDID UDI-DI 10705037048755 listed 16 Dec 2025 Listed
Timeline
- Cleared FDA 510(k) K181472
- Listed FDA GUDID 10705037048755
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Aerozyme™ Xtra
- Generic name
- Medical device cleaning agent
- Model / Ref / Catalog
- 25520
- Primary DI / UDI-DI
- 10705037048755
- 510(k) Number
- FDA product code
- MED
- GMDN term
- Medical device cleaning agent
- Device class
- Class II
- Regulation number
- 880.6885
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code MED (Sterilant, medical devices).
- WAVICIDE MONITOR STRIPS by SERIM RESEARCH CORP.
- PROCIDE 14 N.S., OMNICIDE/LIQUID & PLUS LIQ ACTIVATOR by Cottrell, Ltd.
- PERACT 20 LIQUID STERILANT by Minntech Corp.
- SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 by STERIS CORPORATION
- SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM by STERIS CORPORATION
- ENDO-SPOR PLUS / HYPROCIDE by Cottrell, Ltd.
- SPORICIDIN STERILIZING AND DISINFECTING SOLUTION (SSDS) by Sporicidin Intl.
- ALDAHOL III HIGH-LEVEL DISINFECTANT by Healthpoint, Ltd.
- VAPO-SOLUTION FOR USE IN MDT HARVEY CHEMICLAVE STERILIZERS, MODELS 5000, 5500, AND 6000 by Roger L. Goodman, D.D.S., P.C.
- SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 Endo Liquid Chemical Sterilant Processing System by Steris Corporations
Other devices from Advanced Sterilization Products, Inc.
See all devices from Advanced Sterilization Products, Inc. →