510(k) · Cleared
ClearedSteroScope® Sterilization Technology System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ideate Medical, Inc. · MLR Sterilizer, Chemical
Cleared on Jun 27, 2024 as substantially equivalent to K111377 (Advanced Sterilization Products, 2012) after a 216-day review. Its family tree reaches back 3 generations to 1999.
- Decided
- Jun 27, 2024
- Review
- 216 days
- Class
- Class II
- Product code
- MLR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K981625 (1999). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK981625 Sterrad 50 SterilizerAdvanced Sterilization Products · 1999 · Recalled
- 2 generations backK023290 Sterrad 50 & Sterrad 100S SterilizersAdvanced Sterilization Products · 2003 · Recalled
- 1 generation backK111377 Sterrad (R) 100NX Sterilizer Duo CycleAdvanced Sterilization Products · 2012 · Recalled
- This deviceK233762 SteroScope® Sterilization Technology SystemIdeate Medical, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K981625 | Sterrad 50 Sterilizer | Advanced Sterilization Products | 1999 | 5 |
| −2 | K023290 | Sterrad 50 & Sterrad 100S Sterilizers | Advanced Sterilization Products | 2003 | 9 |
| −1 | K111377 | Sterrad (R) 100NX Sterilizer Duo Cycle | Advanced Sterilization Products | 2012 | 1 |
| 0 (this device) | K233762 | SteroScope® Sterilization Technology System | Ideate Medical, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MLR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MLR device
- #1 K250802 STERRAD® 100NX Sterilizer with ALLClear™…score 14.0 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K111377 | Sterrad (R) 100NX Sterilizer Duo CycleSummary page 5…lene oxide gas sterilizer (21 CFR 888.6860) Regulatory: Class II Product Code: MLR, Sterilizer, Chemical III. PREDICATE DEVICE STERRAD 100NX DUO Cycle (K111377) Reference Device: STERRAD 100NX EXPRESS Cycle (K092622) IV. DEVICE DESCRIPTION The SteroScope® Sterilization Technology Syste… | 2012 |
| † | K092622 | Sterrad 100NX Sterilizer Express Cycle | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 2 companies; a new generation was cleared every 9.4 years on median.
- 6 of the 6 ancestors have a recall of any class.
- 3 other devices also cite its predicate K111377.
How does its category compare?
All MLR devicesMLR Sterilizer, Chemical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · MLR
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MLR
216in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MLR
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MLR
46in 2025
MAUDE reports naming product code MLR, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 5 | 272 |
| 2008 | 0 | — | 8 | 536 |
| 2009 | 1 | — | 2 | 433 |
| 2010 | 0 | — | 1 | 211 |
| 2011 | 6 | 214 | 2 | 34 |
| 2012 | 2 | — | 3 | 101 |
| 2013 | 1 | — | 9 | 541 |
| 2014 | 2 | — | 3 | 399 |
| 2015 | 1 | — | 0 | 412 |
| 2016 | 4 | 183 | 0 | 286 |
| 2017 | 2 | — | 1 | 279 |
| 2018 | 2 | — | 0 | 289 |
| 2019 | 4 | 90 | 0 | 222 |
| 2020 | 0 | — | 0 | 174 |
| 2021 | 2 | — | 0 | 202 |
| 2022 | 2 | — | 0 | 188 |
| 2023 | 5 | 222 | 0 | 140 |
| 2024 | 3 | 216 | 0 | 44 |
| 2025 | 1 | — | 0 | 46 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The SteroScope® Sterilization Technology System is indicated for the terminal sterilization of cleaned reusable Flexible Endoscopes with up to 8 internal lumens with lumen dimensions of:
• ID of 1.0 mm or larger and a length of 3580 mm or shorter and
• ID of 1.2 mm or larger and a length of 4095 mm or shorter
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233762 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233762: SteroScope® Sterilization Technology System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233762
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026