510(k) · Cleared
ClearedSerim Residual Chlorine Test Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Serim Research Corp. · FKJ Filter, Blood, Dialysis
Cleared on Sep 13, 1990 after a 149-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.
- Decided
- Sep 13, 1990
- Review
- 149 days
- Class
- Class II
- Product code
- FKJ
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK901734 Serim Residual Chlorine Test KitSerim Research Corp. · 1990
- Descendant · cites it directly · 0 of its ownK253863 GUARDIAN™ Quick Dip Residual Chlorine (5212)Serim Research · 2026
- Descendant · cites it directly · 0 of its ownK222167 E-Z Chek Chlorine Residual Test Strips (K100-0101B)Reprocessing Products Corporation (Rpc) · 2022
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K901734 | Serim Residual Chlorine Test Kit | Serim Research Corp. | 1990 | — |
| +1 | K253863 | GUARDIAN™ Quick Dip Residual Chlorine (5212) | Serim Research | 2026 | — |
| +1 | K222167 | E-Z Chek Chlorine Residual Test Strips (K100-0101B) | Reprocessing Products Corporation (Rpc) | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2026 | 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 FKJ? 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 FKJ device
- #1 K253863 GUARDIAN™ Quick Dip Residual Chlorine (5212)score 11.0 · 1 generation · no Class I recall
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? (2)
2 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, K253863 (Serim Research, 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All FKJ devicesFKJ Filter, Blood, Dialysis: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FKJ
1so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · FKJ
Too few FKJ 510(k)s in any year since 2007 to give a median.
Recalls per year · FKJ
No recall names FKJ since 2007.
Adverse event reports per year · FKJ
1in 2025
MAUDE reports naming product code FKJ, 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 | 7 |
| 2008 | 0 | — | 0 | 3 |
| 2009 | 0 | — | 0 | 3 |
| 2010 | 0 | — | 0 | 4 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 5 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 48 |
| 2017 | 0 | — | 0 | 11 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 1 | — | 0 | — |
https://510kreport.com/device/K901734 · printed Nov 5, 2026
Cite this page
510(k) Report. “K901734: Serim Residual Chlorine Test Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K901734
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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