510(k) · Cleared
ClearedCidex Formula 7* Long-Life Activated Dialdehyde
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Johnson & Johnson Medical, Inc. · MED Sterilant, Medical Devices
Cleared on Mar 29, 1994 after a 579-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 16 later devices descend from it.
- Decided
- Mar 29, 1994
- Review
- 579 days
- Class
- Class II
- Product code
- MED
- Recalls
- None
- Predicates
- 0
16 later devices descend from it, 3 citing it directly.
- This deviceK924334 Cidex Formula 7* Long-Life Activated DialdehydeJohnson & Johnson Medical, Inc. · 1994
- Descendant · cites it directly · 7 of its ownK972708 Endo-Spor Plus / HyprocideCottrell, Ltd. · 1999
- Descendant · cites it directly · 7 of its ownK970230 SporoxReckitt Benckiser, Inc. · 1997
- 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 · 2 generations on · 3 of its ownK103059 TrophonNanosonics Limited · 2011 · Recalled
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K972708Endo-Spor Plus / HyprocideCottrell, Ltd. · 1999 · cites it directly7descendants
- K970230SporoxReckitt Benckiser, Inc. · 1997 · 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
- K103059TrophonNanosonics Limited · 2011 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K924334 | Cidex Formula 7* Long-Life Activated Dialdehyde | Johnson & Johnson Medical, Inc. | 1994 | — |
| +1 | K972708 | Endo-Spor Plus / Hyprocide | Cottrell, Ltd. | 1999 | — |
| +1 | K970230 | Sporox | Reckitt Benckiser, Inc. | 1997 | — |
| +1 | K013280 | Sterilox Liquid Chemical Sterilant System | Sterilox Technologies, Inc. | 2002 | — |
| +2 | K090036 | System 1.5 Sterile Processing System | STERIS Corporation | 2010 | 6 |
| +2 | K103059 | Trophon | Nanosonics Limited | 2011 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 2 | 0 |
| 2002 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 4 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2018 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 MED? 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 MED device
- #1 K251666 SYSTEM 1E Liquid Chemical Sterilant Processing…score 13.8 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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? (16)
See all 163 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 MED devicesMED Sterilant, Medical Devices: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MED
2in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · MED
84in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MED
2in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MED
9in 2025
MAUDE reports naming product code MED, 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 | — | 3 | 34 |
| 2008 | 1 | — | 2 | 79 |
| 2009 | 0 | — | 0 | 158 |
| 2010 | 6 | 281 | 0 | 89 |
| 2011 | 0 | — | 2 | 106 |
| 2012 | 3 | 111 | 0 | 337 |
| 2013 | 1 | — | 0 | 140 |
| 2014 | 1 | — | 0 | 105 |
| 2015 | 0 | — | 0 | 110 |
| 2016 | 1 | — | 0 | 135 |
| 2017 | 1 | — | 0 | 74 |
| 2018 | 2 | — | 0 | 42 |
| 2019 | 4 | 84 | 0 | 35 |
| 2020 | 0 | — | 0 | 32 |
| 2021 | 2 | — | 0 | 31 |
| 2022 | 1 | — | 0 | 16 |
| 2023 | 2 | — | 0 | 9 |
| 2024 | 0 | — | 0 | 8 |
| 2025 | 0 | — | 0 | 9 |
| 2026 | 2 | — | 0 | — |
https://510kreport.com/device/K924334 · printed Nov 6, 2026
Cite this page
510(k) Report. “K924334: Cidex Formula 7* Long-Life Activated Dialdehyde.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K924334
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026