Sterilucent PSD-85 Hydrogen Peroxide Sterilizer
FDA 510(k) K140464 · Sterilucent, Inc.
510(k) numberK140464
Submission
- Device name
- Sterilucent PSD-85 Hydrogen Peroxide Sterilizer
- Applicant
- Sterilucent, Inc.
Minneapolis, MN, US - Received
- February 24, 2014
- Decision date
- October 31, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MLR – Sterilizer, Chemical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.6860
- Specialty
- General Hospital
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| K231893 | LOWTEM Crystal 120MLR · Traditional | Lowtem Co., Ltd. | 09/18/2024SE |
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| K233762 | SteroScope® Sterilization Technology SystemMLR · Traditional | Ideate Medical, Inc. | 06/27/2024SE |
| K233065 | V-PRO maX 2 Low Temperature Sterilization SystemMLR · Special | Steris | 10/20/2023SE |
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| K223015 | STERLINK FPS-15s Plus sterilizer with STERPACK plus cassetteMLR · Traditional | Plasmapp Co,., Ltd. | 05/09/2023SE |
| K220345 | STERLINK mini Sterilizer with STERLOAD mini Cassette, Tyvek Roll with CI for STERLINK…MLR · Traditional | Plasmapp Co,., Ltd. | 04/14/2023SE |
More from Plasmapp Co,., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K192001 | Sterilucent self-Contained Biological Indicator, Sterilucent Lumen Cycle Process…FRC · Traditional | 10/22/2019SE |
| K191999 | Sterilucent VH2O2 Chemical IndicatorsJOJ · Traditional | 10/21/2019SE |
| K190005 | Sterilucent HC 80TT Hydrogen Peroxide SterilizerMLR · Traditional | 09/13/2019SE |
| K142109 | Sterilucent Sterilization Container SystemKCT · Traditional | 01/20/2015SE |
| K141238 | Sterilucent Self-Contained Biological IndicatorFRC · Traditional | 11/03/2014SE |
| K141312 | Sterilucent Process Challenge DeviceFRC · Traditional | 10/31/2014SE |
Questions and answers
When was Sterilucent PSD-85 Hydrogen Peroxide Sterilizer cleared by the FDA?
Sterilucent PSD-85 Hydrogen Peroxide Sterilizer (K140464) received a 510(k) decision of Substantially Equivalent on October 31, 2014, 249 days after the submission was received.
What is the product code of K140464?
The FDA product code is MLR – Sterilizer, Chemical, a Class II (moderate risk) device regulated under 21 CFR 880.6860.