Steritec Lead Free Sterilization Process Indicator Tape
FDA 510(k) K122555 · Steritec Products Mfg Co, Inc.
510(k) numberK122555
Submission
- Device name
- Steritec Lead Free Sterilization Process Indicator Tape
- Applicant
- Steritec Products Mfg Co, Inc.
Engelwood, CO, US - Received
- August 22, 2012
- Decision date
- December 12, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) statement 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
Other 510(k)s with product code JOJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K200252 | Getinge Assured MI Steam Migrating IntegratorJOJ · Traditional | 05/21/2020SE |
| K133549 | Steritec Biological Test Pack with Instant Readout IntegratorFRC · Traditional | 08/27/2014SE |
| K133322 | Steritec Smart-Read Biological Test Pack with Instant Readout IntegratorFRC · Traditional | 08/25/2014SE |
| K132372 | Steritec Green Card Pack Bowie-Dick TestJOJ · Traditional | 11/26/2013SE |
| K122945 | Steritec Green Card Pack Bowie-Dick Test Model BD 126JOJ · Abbreviated | 04/30/2013SE |
| K111150 | Steritec Smart-Read Biological Test Pack with Instant Readout IntegratorFRC · Traditional | 07/08/2011SE |
| K103000 | Smart Read Biological Test PackJOJ · Special | 02/11/2011SE |
| K072408 | Emu-Graph Emulator, Model Ci 131JOJ · Traditional | 04/30/2008SE |
| K000502 | Steam/Eo Record Card, Model Ci 121JOJ · Special | 03/14/2000SE |
| K990246 | Steri-Pak LF Bowie-Dick Test PackJOJ · Traditional | 06/10/1999SE |
Questions and answers
When was Steritec Lead Free Sterilization Process Indicator Tape cleared by the FDA?
Steritec Lead Free Sterilization Process Indicator Tape (K122555) received a 510(k) decision of Substantially Equivalent on December 12, 2012, 112 days after the submission was received.
What is the product code of K122555?
The FDA product code is JOJ – Indicator, Physical/Chemical Sterilization Process, a Class II (moderate risk) device regulated under 21 CFR 880.2800.