V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 1 Plus Low Temperature Sterilization System, V-PRO 1 Low Temperature Sterilization System
FDA 510(k) K190103 · STERIS Corporation
510(k) numberK190103
Submission
- Device name
- V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 1 Plus Low Temperature Sterilization System, V-PRO 1 Low Temperature Sterilization System
- Applicant
- STERIS Corporation
Mentor, OH, US - Received
- January 22, 2019
- Decision date
- April 5, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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
Other 510(k)s with product code MLR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252843 | STERRAD 100NX Sterilization System with ALLClear Technology (10104)MLR · Traditional | Advanced Sterilization Products, Inc. | 04/15/2026SE |
| K250802 | STERRAD® 100NX Sterilizer with ALLClear Technology (10104)MLR · Traditional | Advanced Sterilization Products, Inc. | 04/14/2025SE |
| K231893 | LOWTEM Crystal 120MLR · Traditional | Lowtem Co., Ltd. | 09/18/2024SE |
| K234082 | STERRAD® 100NX Sterilizer with ALLClear Technology and ULTRA GI Cycle (10104)…MLR · Traditional | Advanced Sterilization Products | 07/05/2024SE |
| 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 |
| K223476 | V-PRO maX 2 Low Temperature Sterilization SystemMLR · Traditional | STERIS Corporation | 08/07/2023SE |
| K231169 | STERLINK plus Sterilizer with STERLOAD Cassette, Tyvek Roll with CI for STERLINK…MLR · Special | Plasmapp Co,., Ltd. | 05/25/2023SE |
| 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 |
|---|---|---|
| K261055 | AMSCO 700 Steam SterilizerFLE · Traditional | 06/24/2026SE |
| K260766 | Celerity 5 HP Biological Indicator (LCB052)FRC · Special | 04/08/2026SE |
| K251666 | SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 endo Liquid…MED · Traditional | 04/08/2026SE |
| K252680 | Celerity 20 HP Biological IndicatorFRC · Special | 09/24/2025SE |
| K251452 | Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059)…FRC · Special | 06/06/2025SE |
| K251048 | Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118JOJ · Special | 05/02/2025SE |
| K243876 | VERIFY STEAM Integrating IndicatorJOJ · Special | 04/25/2025SE |
| K250842 | PADLOCK CLIP EFTR Kit (00713229)PKL · Special | 04/18/2025SE |
| K242773 | Electro Lube NXTGEI · Traditional | 04/15/2025SE |
| K250061 | Celerity IncubatorFRC · Special | 02/06/2025SE |
Questions and answers
When was V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 1 Plus Low Temperature Sterilization System, V-PRO 1 Low Temperature Sterilization System cleared by the FDA?
V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 1 Plus Low Temperature Sterilization System, V-PRO 1 Low Temperature Sterilization System (K190103) received a 510(k) decision of Substantially Equivalent on April 5, 2019, 73 days after the submission was received.
What is the product code of K190103?
The FDA product code is MLR – Sterilizer, Chemical, a Class II (moderate risk) device regulated under 21 CFR 880.6860.