510(k) · Cleared
ClearedFas Endoluminal Brush
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fas Medical, Ltd. · LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Cleared on Oct 15, 2001 as substantially equivalent to K993614 (Fas Medical, Ltd., 2000) and 1 other predicate after a 63-day review. Its family tree reaches back 3 generations to 1982. 1 later device descends from it.
- Decided
- Oct 15, 2001
- Review
- 63 days
- Class
- Class II
- Product code
- LJS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K820771 (1982). 8 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK820771 Microbiology Specimen BrushMill-Rose Laboratory · 1982
- 2 generations backK960880 Mill-Rose Blind Microbiology BrushMill-Rose Laboratory · 1996
- 1 generation backK993614 Fas Endoluminal BrushFas Medical, Ltd. · 2000
- This deviceK012641 Fas Endoluminal BrushFas Medical, Ltd. · 2001
- Descendant · cites it directly · 0 of its ownK072518 CRS Fibrin Analysis Catheter Testing System (Facts)Crs Medical Diagnostics, Inc. · 2007
Most influential descendants
Showing 1 of 1 · See all- K072518CRS Fibrin Analysis Catheter Testing System (Facts)Crs Medical Diagnostics, Inc. · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K820771 | Microbiology Specimen Brush | Mill-Rose Laboratory | 1982 | — |
| −2 | K960880 | Mill-Rose Blind Microbiology Brush | Mill-Rose Laboratory | 1996 | — |
| −1 | K993614 | Fas Endoluminal Brush | Fas Medical, Ltd. | 2000 | — |
| 0 (this device) | K012641 | Fas Endoluminal Brush | Fas Medical, Ltd. | 2001 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 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? (3)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K993614 | Fas Endoluminal Brush Our OCR of the scanned summary read K993613, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “FAS Endoluminal Brush”. | 2000 |
| * | K963925 | Thrombolytic Brush CatheterSummary page 1…atheter Biopsy Brush Classification Name: Intravascular Catheter, Accessory to Proprietary Name: FAS Endoluminal Brush Predicate Devices K993613 FAS Endoluminal Brush K963925 Thrombolytic Brush Catheter K993816 Fogarty Adherent Clot Catheter Device Description The FAS Endoluminal Brush is a single us… | 1997 |
| Kept off the family tree | K993816 | FDA’s K993816 is Baxter Percutaneous Mechanical Thrombectomy (PMT) Device, Models PMT0606FD and… Our OCR of the scanned summary read K993816, FDA’s number for Baxter Percutaneous Mechanical Thrombectomy (PMT) Device… (Baxter Edwards). Its FDA name has none of the distinctive words the summary uses for the device it names, “Fogarty Adherent Clot Catheter”. Kept off the family tree. Summary page 1…ame: Intravascular Catheter, Accessory to Proprietary Name: FAS Endoluminal Brush Predicate Devices K993613 FAS Endoluminal Brush K963925 Thrombolytic Brush Catheter K993816 Fogarty Adherent Clot Catheter Device Description The FAS Endoluminal Brush is a single use, sterile disposable medical device.… | 2000 |
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 |
|---|---|---|---|
| K072518 | CRS Fibrin Analysis Catheter Testing System (Facts) | 2007 | 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 19 years and passes through 2 companies; a new generation was cleared every 3.7 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K072518 (Crs Medical Diagnostics, Inc., 2007) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K993614.
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.
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 FAS Endoluminal Brush 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K012641 · printed Nov 4, 2026
Cite this page
510(k) Report. “K012641: Fas Endoluminal Brush.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012641
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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