510(k) · Cleared
ClearedCRS Fibrin Analysis Catheter Testing System (Facts)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Crs Medical Diagnostics, Inc. · LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Cleared on Dec 20, 2007 as substantially equivalent to K012641 (Fas Medical, Ltd., 2001) and 1 other predicate after a 104-day review. Its family tree reaches back 4 generations to 1982.
- Decided
- Dec 20, 2007
- Review
- 104 days
- Class
- Class II
- Product code
- LJS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K820771 (1982). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK820771 Microbiology Specimen BrushMill-Rose Laboratory · 1982
- 3 generations backK960880 Mill-Rose Blind Microbiology BrushMill-Rose Laboratory · 1996
- 2 generations backK993614 Fas Endoluminal BrushFas Medical, Ltd. · 2000
- 1 generation backK012641 Fas Endoluminal BrushFas Medical, Ltd. · 2001
- This deviceK072518 CRS Fibrin Analysis Catheter Testing System (Facts)Crs Medical Diagnostics, Inc. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K820771 | Microbiology Specimen Brush | Mill-Rose Laboratory | 1982 | — |
| −3 | K960880 | Mill-Rose Blind Microbiology Brush | Mill-Rose Laboratory | 1996 | — |
| −2 | K993614 | Fas Endoluminal Brush | Fas Medical, Ltd. | 2000 | — |
| −1 | K012641 | Fas Endoluminal Brush | Fas Medical, Ltd. | 2001 | — |
| 0 (this device) | K072518 | CRS Fibrin Analysis Catheter Testing System (Facts) | Crs Medical Diagnostics, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1993 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 2005 | 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 LJS? 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 LJS device
- #1 K241910 Neonav ECG Tip Location Systemscore 18.0 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K012641 | Fas Endoluminal BrushSummary page 1…s, implanted, long-term intravascular catheter, product code LJS Common/Usual Name: Endoluminal Brush 2. Equivalent legally marketed devices FAS Endoluminal Brush K012641; CRS Medical Endoluminal Brush K050889 3. Indications for Use (intended use) The CRS Fibrin Analysis Catheter Testing System… | 2001 |
| * | K050889 | Fibrin Analysis System Endoluminal BrushSummary page 1…atheter, product code LJS Common/Usual Name: Endoluminal Brush 2. Equivalent legally marketed devices FAS Endoluminal Brush K012641; CRS Medical Endoluminal Brush K050889 3. Indications for Use (intended use) The CRS Fibrin Analysis Catheter Testing System (FACTS) is intended to collect and remo… | 2005 |
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.
What does this lineage say?
- The line of descent spans 25 years and passes through 3 companies; a new generation was cleared every 6.2 years on median.
- None of the 10 ancestors has a recall.
How does its category compare?
All LJS devicesLJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · LJS
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LJS
171in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LJS
5in 2023
Class I (3 since 2007) Class II/III not classified
Adverse event reports per year · LJS
4,372in 2025
MAUDE reports naming product code LJS, 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 | 14 | 92 | 0 | 392 |
| 2008 | 4 | 97 | 1 | 369 |
| 2009 | 16 | 70 | 1 | 379 |
| 2010 | 9 | 114 | 12 | 495 |
| 2011 | 6 | 55 | 4 | 696 |
| 2012 | 14 | 77 | 40 | 564 |
| 2013 | 14 | 31 | 0 | 680 |
| 2014 | 8 | 47 | 15 | 842 |
| 2015 | 7 | 71 | 2 | 1,306 |
| 2016 | 9 | 128 | 18 | 1,123 |
| 2017 | 7 | 101 | 9 | 2,100 |
| 2018 | 10 | 148 | 3 | 2,324 |
| 2019 | 0 | — | 0 | 2,052 |
| 2020 | 2 | — | 0 | 2,539 |
| 2021 | 3 | 284 | 1 | 3,084 |
| 2022 | 3 | 177 | 0 | 3,256 |
| 2023 | 4 | 47 | 5 (2) | 2,799 |
| 2024 | 1 | — | 0 | 4,243 |
| 2025 | 8 | 171 | 0 | 4,372 |
| 2026 | 2 | — | 8 (1) | — |
What is it indicated for?
The CRS Fibrin Analysis Catheter Testing System (FACTS) is intended to collect and remove obstructing material from the internal lumen surface of an indwelling central venous catheter to restore or improve catheter flow rate, and to provide a biofilm or fibrin sample which is suitable for microbiological analysis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072518 · printed Nov 5, 2026
Cite this page
510(k) Report. “K072518: CRS Fibrin Analysis Catheter Testing System (Facts).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K072518
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026