Kem Medical Lead-free Chemical Indicators for Steam Sterilization
FDA 510(k) clearance K241836 · decided 2024-09-30
Clearance details
- K-number
- K241836
- Device name
- Kem Medical Lead-free Chemical Indicators for Steam Sterilization
- Applicant
- Kem Medical Products Corporation
- Decision
- Substantially Equivalent
- Date received
- 2024-06-25
- Decision date
- 2024-09-30
- Days to decision
- 97 days
- Clearance type
- Traditional
- Product code
- JOJ
- Device class
- 2
- Regulation number
- 880.2800
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Hauppauge, NY, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Kem Medical Products Corporation
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API,
or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|
| LF Process Indicator Tape for Steam Sterilization (K260181) | Intertape Polymer Group | 2026-02-20 |
| SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016); SafeSecure Vaporized Hydrogen Peroxide Sterilization Process Indicator (4211, 4212, 4213) (K251991) | Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd. | 2025-12-23 |
| DISINTEK™ PA Test Strips (K251035) | Serim Research | 2025-06-03 |
| Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118 (K251048) | STERIS Corporation | 2025-05-02 |
| VERIFY STEAM Integrating Indicator (K243876) | STERIS Corporation | 2025-04-25 |
| Green Card Bowie-Dick Test (BD115) (K250172) | Steritec Products, Inc. (A Getinge Company) | 2025-02-20 |
| Type 5 Integrating Indicator for Steam (CSPN-15) (K242860) | True Indicating, LLC | 2025-01-17 |
| Autoclave Indicator Tape; EO Indicator Tape (K241036) | Jiangmen New Era External Use Drug Co., Ltd. | 2024-12-17 |
| Chemical Indicator for enspire CLCSPS (LCC015) (K243475) | STERIS Corporation | 2024-12-04 |
| Getinge Assured MI Steam Migrating Integrator (K242795) | Steritec Products Mfg. (A Getinge Group Company) | 2024-10-15 |
| CELERITY HP Indicator Tape (PCC077) (K242189) | Steris | 2024-08-20 |
| STERRAD™ Chemical Indicator (CI) Strip (14100); STERRAD® SEALSURE® Chemical Indicator (CI) Tape (14202NL); STERRAD VELOCITY™ Biological Indicator (BI) (43210) (60 count); STERRAD VELOCITY™ Biological Indicator (BI) (43210-30)(30 count); STERRAD VELOCITY™ Reader (43220); ULTRA GI™ Process Challenge Device (PCD) (43400)(30 count) (K234084) | Advanced Sterilization Products, Inc. | 2024-07-05 |
Recalls involving this device
No recalls on record reference this clearance.