510(k) · Cleared
Recalled · Class II · 2012Cavicide Surface Disinfectant/Decontaminant Cleaner
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Micro-Aseptic Products, Inc. · LRJ Disinfectant, Medical Devices
Cleared on Apr 25, 1995 after a 60-day review. FDA has not posted a summary or statement for it, so its predicates are not known. It has been recalled once.
- Decided
- Apr 25, 1995
- Review
- 60 days
- Class
- Class I
- Product code
- LRJ
- Recalls
- 1
- Predicates
- 0
FDA has not posted a summary or statement for it, so its predicates are not known.
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?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 6, 2012 | Class II | Z-2267-2012 | Component change control | Metrex Research is recalling Cavicide containing the Spring Fresh Fragrance because the affected lot of product containing this fragance has caused an increase in reported health reactions in some individuals such as headache, nausea, and… |
No ancestor or descendant has a Class I recall.
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/K951123 · printed Nov 6, 2026
Cite this page
510(k) Report. “K951123: Cavicide Surface Disinfectant/Decontaminant Cleaner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K951123
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026