510(k) · Cleared
Recalled · Class II · 2020Diatek Connector Assembly Replacement Kit (Cark)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diatek, Inc. · NFK Kit, Repair, Catheter, Hemodialysis
Cleared on May 9, 2002 as substantially equivalent to K010399 (Diatek, Inc., 2001) after a 90-day review. Its family tree reaches back 1 generation to 2001. 1 of the 3 devices in its family, counting itself, has a Class I recall. 1 later device descends from it. It has been recalled 2 times.
- Decided
- May 9, 2002
- Review
- 90 days
- Class
- Class II
- Product code
- NFK
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K010399 (2001). 1 later device descends from it, 1 citing it directly. 1 of the 3 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK010399 Diatek Cannon-Cath #CC2400, CC2800, CC3200, CC3600,CC5500. CC2400PC…Diatek, Inc. · 2001 · Recalled
- This deviceK020430 Diatek Connector Assembly Replacement Kit (Cark)Diatek, Inc. · 2002
- Descendant · cites it directly · 0 of its ownK141051 Vectorflow; Antegrade Chronic Hemodialysis Catheter, Retrograde…Arrow International, Inc. · 2014 · Recalled (Class I)
Class I recalls in this family
- K141051 Vectorflow; Antegrade Chronic Hemodialysis…cites it directly · 2014
Most influential descendants
Showing 1 of 1 · See all- K141051Vectorflow; Antegrade Chronic Hemodialysis Catheter, Retrograde Chronic Hemodialysis…Arrow International, Inc. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K010399 | Diatek Cannon-Cath #CC2400, CC2800, CC3200, CC3600,CC5500. CC2400PC, CC2800PC… | Diatek, Inc. | 2001 | 2 |
| 0 (this device) | K020430 | Diatek Connector Assembly Replacement Kit (Cark) | Diatek, Inc. | 2002 | — |
| +1 | K141051 | Vectorflow; Antegrade Chronic Hemodialysis Catheter, Retrograde Chronic… | Arrow International, Inc. | 2014 | Class I |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 1 |
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.
1 device in this family has a Class I recall. 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? (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 |
|---|---|---|---|
| * | K010399 | Diatek Cannon-Cath #CC2400, CC2800, CC3200, CC3600,CC5500. CC2400PC, CC2800PC, CC3200PC…Summary page 1…mponents in the Diatek Cannon-Cath product have been tested by both internal and outside laboratories for a range of criteria and found acceptable as submitted in 510(k) 010399 for the predicate device. o eIy, & %, £ ( DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service o, R Food… | 2001 |
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 |
|---|---|---|---|
| K141051 | Vectorflow; Antegrade Chronic Hemodialysis Catheter, Retrograde Chronic Hemodialysis… Class I | 2014 | 0 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 6, 2020 | Class II | Z-2802-2020 | Incorrect or no expiration date | The lidstock states the incorrect expiration date for the product. This issue could result in use of a device that is expired which could potentially lead to an increased risk of infection or other complications. Sterility… |
| Jul 6, 2020 | Class II | Z-2804-2020 | Incorrect or no expiration date | The lidstock states the incorrect expiration date for the product. This issue could result in use of a device that is expired which could potentially lead to an increased risk of infection or other complications. Sterility… |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K141051Vectorflow; Antegrade Chronic Hemodialysis Catheter, Retrograde Chronic Hemodialysis Catheter, Retrograde…Arrow International, Inc. · 2014 · Cites it directly · ◆ in the 2014 descendants bar of FIG. 11 Class I recall
What does this lineage say?
How does its category compare?
All NFK devicesNFK Kit, Repair, Catheter, Hemodialysis: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NFK
1in 2010
2026 to Oct 25, outlined.
Median 510(k) review, days · NFK
Too few NFK 510(k)s in any year since 2007 to give a median.
Recalls per year · NFK
No recall names NFK since 2007.
Adverse event reports per year · NFK
18in 2025
MAUDE reports naming product code NFK, 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 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 2 |
| 2010 | 1 | — | 0 | 3 |
| 2011 | 0 | — | 0 | 16 |
| 2012 | 0 | — | 0 | 11 |
| 2013 | 0 | — | 0 | 16 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 7 |
| 2017 | 0 | — | 0 | 8 |
| 2018 | 0 | — | 0 | 5 |
| 2019 | 0 | — | 0 | 5 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 18 |
| 2023 | 0 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 19 |
| 2025 | 0 | — | 0 | 18 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Diatek Connector Assembly Replacement Kit is to be used for replacing the original connector assembly on a Diatek Cannon-Cath Dialysis Catheter if the connector assembly becomes damaged or dysfunctional. This prevents the patient from requiring additional surgery for catheter removal and replacement.
The Connector Assembly Replacement Kit is intended for use in any patient who has a previously implanted Diatek Cannon-Cath Dialysis Catheter implanted.
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/K020430 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020430: Diatek Connector Assembly Replacement Kit (Cark).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020430
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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