510(k) · Cleared
ClearedCidex Activated Dialdehyde Solution
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Johnson & Johnson Medical, Inc. · LRJ Disinfectant, Medical Devices
Cleared on Mar 29, 1994 after a 574-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 9 later devices descend from it.
- Decided
- Mar 29, 1994
- Review
- 574 days
- Class
- Class I
- Product code
- LRJ
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 3 citing it directly.
- This deviceK924434 Cidex Activated Dialdehyde SolutionJohnson & Johnson Medical, Inc. · 1994
- Descendant · cites it directly · 7 of its ownK972708 Endo-Spor Plus / HyprocideCottrell, Ltd. · 1999
- Descendant · cites it directly · 6 of its ownK013280 Sterilox Liquid Chemical Sterilant SystemSterilox Technologies, Inc. · 2002
- Descendant · 2 generations on · 4 of its ownK090036 System 1.5 Sterile Processing SystemSTERIS Corporation · 2010 · Recalled
- Descendant · 3 generations on · 3 of its ownK101409 System IE Liquid Chemical Cterilant Processing SystemSTERIS Corporation · 2010 · Recalled
- Descendant · 3 generations on · 2 of its ownK102462 System 1E Liquid Chemical Sterilant Processing SystemSTERIS Corporation · 2010 · Recalled
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K972708Endo-Spor Plus / HyprocideCottrell, Ltd. · 1999 · cites it directly7descendants
- K013280Sterilox Liquid Chemical Sterilant SystemSterilox Technologies, Inc. · 2002 · cites it directly6descendants
- K090036System 1.5 Sterile Processing SystemSTERIS Corporation · 2010 · 2 generations on4descendants
- K101409System IE Liquid Chemical Cterilant Processing SystemSTERIS Corporation · 2010 · 3 generations on3descendants
- K102462System 1E Liquid Chemical Sterilant Processing SystemSTERIS Corporation · 2010 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K924434 | Cidex Activated Dialdehyde Solution | Johnson & Johnson Medical, Inc. | 1994 | — |
| +1 | K972708 | Endo-Spor Plus / Hyprocide | Cottrell, Ltd. | 1999 | — |
| +1 | K013280 | Sterilox Liquid Chemical Sterilant System | Sterilox Technologies, Inc. | 2002 | — |
| +2 | K090036 | System 1.5 Sterile Processing System | STERIS Corporation | 2010 | 6 |
| +3 | K101409 | System IE Liquid Chemical Cterilant Processing System | STERIS Corporation | 2010 | 4 |
| +3 | K102462 | System 1E Liquid Chemical Sterilant Processing System | STERIS Corporation | 2010 | 5 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LRJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (9)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K972708 (Cottrell, Ltd., 1999) has gone furthest, with 7 descendants of its own.
How does its category compare?
All LRJ devicesLRJ Disinfectant, Medical Devices: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LRJ
FDA has decided no LRJ device since 2007.
Median 510(k) review, days · LRJ
Too few LRJ 510(k)s in any year since 2007 to give a median.
Recalls per year · LRJ
4so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LRJ
70in 2025
MAUDE reports naming product code LRJ, 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 | 0 | — | 0 | 126 |
| 2008 | 0 | — | 0 | 72 |
| 2009 | 0 | — | 1 | 39 |
| 2010 | 0 | — | 0 | 18 |
| 2011 | 0 | — | 0 | 40 |
| 2012 | 0 | — | 0 | 37 |
| 2013 | 0 | — | 1 | 31 |
| 2014 | 0 | — | 0 | 18 |
| 2015 | 0 | — | 0 | 15 |
| 2016 | 0 | — | 0 | 13 |
| 2017 | 0 | — | 0 | 6 |
| 2018 | 0 | — | 0 | 15 |
| 2019 | 0 | — | 0 | 12 |
| 2020 | 0 | — | 0 | 73 |
| 2021 | 0 | — | 1 | 497 |
| 2022 | 0 | — | 0 | 171 |
| 2023 | 0 | — | 0 | 95 |
| 2024 | 0 | — | 0 | 116 |
| 2025 | 0 | — | 0 | 70 |
| 2026 | 0 | — | 4 | — |
https://510kreport.com/device/K924434 · printed Nov 4, 2026
Cite this page
510(k) Report. “K924434: Cidex Activated Dialdehyde Solution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K924434
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026