510(k) · Cleared
ClearedSerim Blood Leak Test Strip-2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Serim Research Corp. · FJD Detector, Leak, Blood
Cleared on Nov 30, 2001 as substantially equivalent to K896454 (Boehringer Mannheim Corp., 1990) and 1 other predicate after a 147-day review. Its family tree reaches back 2 generations to 1990. 1 later device descends from it.
- Decided
- Nov 30, 2001
- Review
- 147 days
- Class
- Class II
- Product code
- FJD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K896454 (1990). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK896454 Chemstrip (R) 10 with SG Urine Test StripsBoehringer Mannheim Corp. · 1990
- 1 generation backK990206 Serim Blood Leak Test StripSerim Research Corp. · 1999
- This deviceK012115 Serim Blood Leak Test Strip-2Serim Research Corp. · 2001
- Descendant · cites it directly · 0 of its ownK042322 Sterichek Blood Leak Reagent StripsHach Company · 2004
Most influential descendants
Showing 1 of 1 · See all- K042322Sterichek Blood Leak Reagent StripsHach Company · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K896454 | Chemstrip (R) 10 with SG Urine Test Strips | Boehringer Mannheim Corp. | 1990 | — |
| −1 | K990206 | Serim Blood Leak Test Strip | Serim Research Corp. | 1999 | — |
| 0 (this device) | K012115 | Serim Blood Leak Test Strip-2 | Serim Research Corp. | 2001 | — |
| +1 | K042322 | Sterichek Blood Leak Reagent Strips | Hach Company | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
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 FJD? 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? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K896454 | Chemstrip (R) 10 with SG Urine Test StripsSummary page 1…nd function to the occult blood test pad on Chemstrip 10 urine test strip manufactured by Boehringer Mannheim Corporation which was the subject of Premarket Notification K896454 The product is similar in utility to the cyanomethemoglobin assay. Supportive data for substantial equivalence to the latter was… | 1990 |
| * | K990206 | Serim Blood Leak Test StripSummary page 2…responds to approximately 0.1 mL/minute blood loss. Serim Blood Leak Test Strips-2 are similar in function to Serim Blood Leak Test Strips-1, premarket notification no. K990206, currently being marketed to dialysis clinics. The formulation in Serim Blood Leak Test Strips-2 was changed for proprietary reas… | 1999 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042322 | Sterichek Blood Leak Reagent Strips | 2004 | 0 |
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?
- The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 9.3 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K042322 (Hach Company, 2004) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K896454.
How does its category compare?
All FJD devicesFJD Detector, Leak, Blood: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FJD
1in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · FJD
Too few FJD 510(k)s in any year since 2007 to give a median.
Recalls per year · FJD
No recall names FJD since 2007.
Adverse event reports per year · FJD
1in 2025
MAUDE reports naming product code FJD, 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 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Serim Blood Leak Test Strips —2 provide a rapid and convenient means for testing dialysate for blood if a dialyzer membrane leak is suspected during the conventional hemodialysis procedure or continuous renal replacement therapy procedures such as continuous arteriovenous hemodialysis or continuous venovenous hemodialysis.
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/K012115 · printed Nov 3, 2026
Cite this page
510(k) Report. “K012115: Serim Blood Leak Test Strip-2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K012115
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026