U&U Indicator tape and strip
FDA 510(k) K171823 · U&U Medical Technology Co, Ltd.
510(k) numberK171823
Submission
- Device name
- U&U Indicator tape and strip
- Applicant
- U&U Medical Technology Co, Ltd.
Changzhou, CN - Received
- June 19, 2017
- Decision date
- February 22, 2018
- 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
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 |
|---|---|---|
| K181508 | U&U Blood Collection SetsFMI · Traditional | 02/13/2019SE |
| K160855 | U&U Enteral SyringePNR · Traditional | 11/22/2016SE |
| K152808 | U&U Insulin Syringe with/without Safety Retractable DeviceMEG · Traditional | 03/25/2016SE |
| K151151 | U & U Intravascular Administration SetFPA · Traditional | 09/24/2015SE |
| K143637 | U&U Sterilization Pouch and RollFRG · Traditional | 09/09/2015SE |
| K143629 | U&U Bowie-Dick Test PackJOJ · Traditional | 05/19/2015SE |
| K132553 | U&U Sterile Piston Syringe Without NeedleFMF · Traditional | 02/27/2014SE |
| K123162 | U&U Hydrogen Peroxide Gas Plasma Sterilization Pouch/RollFRG · Traditional | 02/26/2014SE |
| K132552 | U&U Sterile Hypodermic NeedleFMI · Traditional | 11/13/2013SE |
Questions and answers
When was U&U Indicator tape and strip cleared by the FDA?
U&U Indicator tape and strip (K171823) received a 510(k) decision of Substantially Equivalent on February 22, 2018, 248 days after the submission was received.
What is the product code of K171823?
The FDA product code is JOJ – Indicator, Physical/Chemical Sterilization Process, a Class II (moderate risk) device regulated under 21 CFR 880.2800.