510(k) · Cleared
ClearedFibrex Catheter Patency Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Device Technologies, Inc. · FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Cleared on May 3, 2004 as substantially equivalent to K021606 (Medical Device Technologies, Inc., 2002) after a 74-day review. Its family tree reaches back 3 generations to 1990.
- Decided
- May 3, 2004
- Review
- 74 days
- Class
- Class II
- Product code
- FOZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K901502 (1990). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK901502 Amplatz Goose-Neck SnareMicrovena Corp. · 1990 · Recalled
- 2 generations backK972511 Amplatz Goose Neck Snare Kit/ CatheterMicrovena Corp. · 1998 · Recalled
- 1 generation backK021606 EN-Snare Endovascular Snare and CatheterMedical Device Technologies, Inc. · 2002
- This deviceK040427 Fibrex Catheter Patency DeviceMedical Device Technologies, Inc. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K901502 | Amplatz Goose-Neck Snare | Microvena Corp. | 1990 | 1 |
| −2 | K972511 | Amplatz Goose Neck Snare Kit/ Catheter | Microvena Corp. | 1998 | 1 |
| −1 | K021606 | EN-Snare Endovascular Snare and Catheter | Medical Device Technologies, Inc. | 2002 | — |
| 0 (this device) | K040427 | Fibrex Catheter Patency Device | Medical Device Technologies, Inc. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1993 | 2 | 0 |
| 1998 | 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 FOZ? 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 FOZ device
- #1 K243403 BD Nexiva™ Closed IV Catheter Systemscore 14.8 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K021606 | EN-Snare Endovascular Snare and CatheterSummary page 1…Product Name 510(k) No. Medical Device Technologies En-Snare Tm Endovascular Snare and Catheter K02 1606 DESCRIPTION OF DEVICE: The FibreXTM Catheter Patency Device is a tni-axial delivery catheter assembly comprised of an outer cat… | 2002 |
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 14 years and passes through 2 companies; a new generation was cleared every 4.2 years on median.
- 2 of the 7 ancestors have a recall of any class.
- 1 other device also cites its predicate K021606.
How does its category compare?
All FOZ devicesFOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FOZ
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FOZ
91in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FOZ
4in 2023
Class I (5 since 2007) Class II/III not classified
Adverse event reports per year · FOZ
5,110in 2025
MAUDE reports naming product code FOZ, 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 | 6 | 159 | 16 | 374 |
| 2008 | 9 | 103 | 0 | 422 |
| 2009 | 9 | 30 | 23 | 508 |
| 2010 | 3 | 28 | 115 | 370 |
| 2011 | 6 | 132 | 0 | 786 |
| 2012 | 13 | 122 | 0 | 560 |
| 2013 | 4 | 104 | 2 | 640 |
| 2014 | 9 | 99 | 4 | 815 |
| 2015 | 10 | 107 | 0 | 729 |
| 2016 | 9 | 63 | 3 (1) | 925 |
| 2017 | 9 | 51 | 22 | 1,966 |
| 2018 | 1 | — | 4 | 3,305 |
| 2019 | 8 | 140 | 3 | 4,365 |
| 2020 | 10 | 191 | 3 | 3,797 |
| 2021 | 4 | 242 | 1 | 4,674 |
| 2022 | 8 | 183 | 4 (2) | 4,133 |
| 2023 | 9 | 129 | 4 (2) | 4,430 |
| 2024 | 6 | 190 | 0 | 4,772 |
| 2025 | 11 | 91 | 0 | 5,110 |
| 2026 | 7 | 203 | 2 | — |
What is it indicated for?
The FibrexTM Catheter Patency Device is intended to disrupt fibrin sheath formation on both the external and internal surface of vascular access catheters, thus restoring functional patency.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040427 · printed Nov 5, 2026
Cite this page
510(k) Report. “K040427: Fibrex Catheter Patency Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K040427
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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