AN1087 Dosimeter
FDA 510(k) K150645 · Andersen Sterilizers, Inc.
510(k) numberK150645
Submission
- Device name
- AN1087 Dosimeter
- Applicant
- Andersen Sterilizers, Inc.
Haw River, NC, US - Received
- March 12, 2015
- Decision date
- November 19, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JOJ – Indicator, Physical/Chemical Sterilization Process
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.2800
- Specialty
- General Hospital
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| K260181 | LF Process Indicator Tape for Steam SterilizationJOJ · Special | Intertape Polymer Group | 02/20/2026SE |
| K251991 | SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016); SafeSecure…JOJ · Traditional | Shenzhen Safesecure Medical Infection Control… | 12/23/2025SE |
| K251035 | DISINTEK PA Test StripsJOJ · Traditional | Serim Research | 06/03/2025SE |
| K251048 | Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118JOJ · Special | STERIS Corporation | 05/02/2025SE |
| K243876 | VERIFY STEAM Integrating IndicatorJOJ · Special | STERIS Corporation | 04/25/2025SE |
| K250172 | Green Card Bowie-Dick Test (BD115)JOJ · Special | Steritec Products, Inc. (A Getinge Company) | 02/20/2025SE |
| K242860 | Type 5 Integrating Indicator for Steam (CSPN-15)JOJ · Traditional | True Indicating, LLC | 01/17/2025SE |
| K241036 | Autoclave Indicator Tape; EO Indicator TapeJOJ · Traditional | Jiangmen New Era External Use Drug Co., Ltd. | 12/17/2024SE |
| K243475 | Chemical Indicator for enspire CLCSPS (LCC015)JOJ · Special | STERIS Corporation | 12/04/2024SE |
| K242795 | Getinge Assured MI Steam Migrating IntegratorJOJ · Special | Steritec Products Mfg. (A Getinge Group Company) | 10/15/2024SE |
More from Steritec Products Mfg. (A Getinge Group Company)
| 510(k) | Device | Decision |
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| K213296 | Anprolene SteriTest RRBIFRC · Traditional | 04/12/2022SE |
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| K200336 | Tyvek Sterilization Pouches with Chevron SealFRG · Traditional | 11/12/2020SE |
| K200335 | Sterisheet Sterilization WrapFRG · Traditional | 11/12/2020SE |
| K200334 | AN1036 DosimeterJOJ · Traditional | 11/12/2020SE |
| K192980 | EOGas 4 Endo-SteriTestFRC · Traditional | 11/12/2020SE |
| K192978 | EOGas 4 Ethylene Oxide Gas SterilizerFLF · Traditional | 11/12/2020SE |
| K170439 | AN87 DosimeterJOJ · Traditional | 11/01/2017SE |
| K170437 | Sterisheet Sterilization WrapFRG · Traditional | 11/01/2017SE |
| K170432 | Anprolene AN75 Ethylene Oxide Gas SterilizerFLF · Traditional | 10/31/2017SE |
Questions and answers
When was AN1087 Dosimeter cleared by the FDA?
AN1087 Dosimeter (K150645) received a 510(k) decision of Substantially Equivalent on November 19, 2015, 252 days after the submission was received.
What is the product code of K150645?
The FDA product code is JOJ – Indicator, Physical/Chemical Sterilization Process, a Class II (moderate risk) device regulated under 21 CFR 880.2800.