510(k) · Cleared
ClearedPro-Portion Cleaner/Disinfectant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sultan Chemists, Inc. · LRJ Disinfectant, Medical Devices
Cleared on Jul 14, 1999 after a 75-day review. The FDA summary names no predicate by number.
- Decided
- Jul 14, 1999
- Review
- 75 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?
Pro-Portion is a general-purpose cleaner/disinfectant. Its use is restricted to
a health care setting where low and intermediate level disinfection of hard,
non-porous surfaces is required. It is intended to be used in a dental office
as an instrument ultrasonic cleaning solution. In order to disinfect, a contact
time of 10 minutes at 69°F / 20°C is required.
This product may be used to pre-clean or decontaminate of critical or non-
critical medical devices prior to sterilization. Must be followed by
appropriate terminal sterilization or high-level disinfection process.
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/K991509 · printed Nov 4, 2026
Cite this page
510(k) Report. “K991509: Pro-Portion Cleaner/Disinfectant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991509
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026