3M Comply 1249 Liquid Peracetic Acid Chemical Indicator
FDA 510(k) K000355 · Minnesota Mining and Mfg. Co.
510(k) numberK000355
Submission
- Device name
- 3M Comply 1249 Liquid Peracetic Acid Chemical Indicator
- Applicant
- Minnesota Mining and Mfg. Co.
St. Paul, MN, US - Received
- February 4, 2000
- Decision date
- August 23, 2000
- 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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| 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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| K013228 | 3M Comply 1248 Gas Plasma Chemical IndicatorJOJ · Traditional | 01/18/2002SE |
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| K990482 | 3M Clinpro Prophy Paste, Model 12611EJR · Traditional | 05/13/1999SE |
| K961848 | 3M Littmann Electronic StethoscopeDQD · Traditional | 09/26/1997SE |
| K965043 | 3M 1830 Fluid Block Anti-Fog Tie-On Surgical Mask and 3M 1830FS Fluid Block Anti-Fog…FXX · Traditional | 03/10/1997SE |
| K954900 | 3M Red Dot ECG Lead Wires aDSA · Traditional | 07/15/1996SE |
| K940446 | 3M Model 3000 & Model 3100 Infusion Pump (Modification)FRN · Traditional | 08/15/1994ST |
| K837117 | 3M Ferlic Chest Filter, X-Ray Compensating Filter · Traditional | 03/09/1983SE |
Questions and answers
When was 3M Comply 1249 Liquid Peracetic Acid Chemical Indicator cleared by the FDA?
3M Comply 1249 Liquid Peracetic Acid Chemical Indicator (K000355) received a 510(k) decision of Substantially Equivalent on August 23, 2000, 201 days after the submission was received.
What is the product code of K000355?
The FDA product code is JOJ – Indicator, Physical/Chemical Sterilization Process, a Class II (moderate risk) device regulated under 21 CFR 880.2800.