Rapicide OPA-28
FDA 510(k) K120306 · Minntech Corp.
510(k) numberK120306
Submission
- Device name
- Rapicide OPA-28
- Applicant
- Minntech Corp.
Minneapolis, MN, US - Received
- February 1, 2012
- Decision date
- September 27, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MED – Sterilant, Medical Devices
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.6885
- Specialty
- General Hospital
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| K251666 | SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 endo Liquid…MED · Traditional | STERIS Corporation | 04/08/2026SE |
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| K190104 | SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 Endo Liquid Chemical…MED · Special | Steris Corporations | 03/22/2019SE |
| K182827 | SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model 6900MED · Traditional | STERIS Corporation | 01/31/2019SE |
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Questions and answers
When was Rapicide OPA-28 cleared by the FDA?
Rapicide OPA-28 (K120306) received a 510(k) decision of Substantially Equivalent on September 27, 2012, 239 days after the submission was received.
What is the product code of K120306?
The FDA product code is MED – Sterilant, Medical Devices, a Class II (moderate risk) device regulated under 21 CFR 880.6885.