510(k) · Cleared
ClearedLow PH Phenolic 256
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Central Solutions, Inc. · LRJ Disinfectant, Medical Devices
Cleared on Nov 6, 1998 after a 24-day review. The FDA summary names no predicate by number.
- Decided
- Nov 6, 1998
- Review
- 24 days
- Class
- Class I
- Product code
- LRJ
- Recalls
- None
- Predicates
- 0
The FDA summary names no predicate by number.
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 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?
The FDA summary names no predicate by number.
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.
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 | — |
What is it indicated for?
For use in health care settings for low and intermediate level disinfection of hard, non-porous, inanimate surfaces of wheelchairs, medical beds, patient transfer lifts, crutches, instrument trays, operating tables, stethoscopes, bedpans, blood donor chairs, dental chairs, medical lamps, whirlpool bathing units, and other medical devices that require low or intermediate level disinfection. This product may be used to preclean or decontaminate critical or non-critical medical devices prior to sterilization or high-level disinfection.
The effectiveness of this product has been documented at a temperature of 88°F (20°C), with a ten minute contact time on the surface being treated.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K983585 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983585: Low PH Phenolic 256.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983585
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026