SteroScope® Sterilization Technology System
FDA 510(k) K233762 · Ideate Medical, Inc.
510(k) numberK233762
Submission
- Device name
- SteroScope® Sterilization Technology System
- Applicant
- Ideate Medical, Inc.
St. Louis, MO, US - Received
- November 24, 2023
- Decision date
- June 27, 2024
- 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
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 |
| 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 |
| K222093 | V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature…MLR · Special | Steris | 09/09/2022SE |
Questions and answers
When was SteroScope® Sterilization Technology System cleared by the FDA?
SteroScope® Sterilization Technology System (K233762) received a 510(k) decision of Substantially Equivalent on June 27, 2024, 216 days after the submission was received.
What is the product code of K233762?
The FDA product code is MLR – Sterilizer, Chemical, a Class II (moderate risk) device regulated under 21 CFR 880.6860.