510(k) · Cleared
ClearedSupercath V
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Togo Medikit Co., Ltd. · FIE Needle, Fistula
Cleared on Oct 27, 2006 as substantially equivalent to K030571 (Ethicon Endo-Surgery, Inc., 2003) and 2 other predicates after a 434-day review. Its family tree reaches back 2 generations to 1986.
- Decided
- Oct 27, 2006
- Review
- 434 days
- Class
- Class II
- Product code
- FIE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K854773 (1986). 4 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K854773 | Supercath a.V. Fistula | Togo Medikit Co., Ltd. | 1986 | — |
| −1 | K050114 | Supercath Z3V | Togo Medikit Co., Ltd. | 2005 | — |
| 0 (this device) | K052267 | Supercath V | Togo Medikit Co., Ltd. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 2003 | 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 FIE? 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 FIE device
- #1 K253469 Ritus™ Safety Fistula Cannula with Anti-Reflux…score 13.0 · 5 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K030571 | Acuvance Plus Safety IV Catheter, Protectiv Plus Safety IV Catheter, Optiva IV CatheterSummary page 1…eedle Classification Name: Blood access device and accessories e. Predicate devices This device is substantially equivalent to "PROTECTJV PLUS Safety IV Catheter" (K030571), Togo Medikit's Supercath AMV Fistula (K854773) and Supercath Z3V (K0501 14). f. Device description The SUPERCATH V fistu… | 2003 |
| * | K854773 | Supercath a.V. FistulaSummary page 1…nd accessories e. Predicate devices This device is substantially equivalent to "PROTECTJV PLUS Safety IV Catheter" (K030571), Togo Medikit's Supercath AMV Fistula (K854773) and Supercath Z3V (K0501 14). f. Device description The SUPERCATH V fistula catheter is part of any hemnodialysis system… | 1986 |
| * | K050114 | Supercath Z3VSummary page 1…devices This device is substantially equivalent to "PROTECTJV PLUS Safety IV Catheter" (K030571), Togo Medikit's Supercath AMV Fistula (K854773) and Supercath Z3V (K0501 14). f. Device description The SUPERCATH V fistula catheter is part of any hemnodialysis system that connects the patient to… | 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 20 years and passes through 1 company; a new generation was cleared every 19.2 years on median.
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate K030571.
How does its category compare?
All FIE devicesFIE Needle, Fistula: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FIE
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FIE
91in 2011
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FIE
3in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FIE
33in 2025
MAUDE reports naming product code FIE, 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 | 3 | 90 | 0 | 13 |
| 2008 | 0 | — | 0 | 10 |
| 2009 | 1 | — | 0 | 27 |
| 2010 | 3 | 29 | 0 | 17 |
| 2011 | 3 | 91 | 0 | 2 |
| 2012 | 1 | — | 3 | 7 |
| 2013 | 0 | — | 0 | 6 |
| 2014 | 2 | — | 0 | 4 |
| 2015 | 2 | — | 0 | 23 |
| 2016 | 0 | — | 0 | 21 |
| 2017 | 1 | — | 0 | 14 |
| 2018 | 1 | — | 0 | 16 |
| 2019 | 0 | — | 0 | 21 |
| 2020 | 0 | — | 0 | 3 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 1 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 58 |
| 2024 | 0 | — | 0 | 14 |
| 2025 | 1 | — | 0 | 33 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Supercath V fistula catheter is intended to access a vein or artery while connected to a blood circuit during kidney dialysis. The Supercath V is intended to minimize inadvertent needlestieks or is intended to reduce accidental needlesticks.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052267 · printed Nov 5, 2026
Cite this page
510(k) Report. “K052267: Supercath V.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K052267
Report an extraction error
Are you the manufacturer?
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