510(k) · Cleared
ClearedPolyplex Stimulating Catheter System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Te ME NA Sas · CAZ Anesthesia Conduction Kit
Cleared on Jul 18, 2006 as substantially equivalent to K991259 (Te ME NA S.A.R.L., 2001) and 1 other predicate after a 175-day review. Its family tree reaches back 2 generations to 1980. 1 of the 6 devices in its family, counting itself, has a Class I recall.
- Decided
- Jul 18, 2006
- Review
- 175 days
- Class
- Class II
- Product code
- CAZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K801912 (1980). 5 ancestors in all. No later device cites it as a predicate yet. 1 of the 6 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK801912 Arrow Positive Placement Con/Epidural anArrow Intl., Inc. · 1980 · Recalled (Class I)
- 1 generation backK021567 Stimucath Continuous Nerve Block Set, Product Number AB-05000Arrow Intl., Inc. · 2002 · Recalled
- This deviceK060186 Polyplex Stimulating Catheter SystemTe ME NA Sas · 2006
Class I recalls in this family
- K801912 Arrow Positive Placement Con/Epidural an2 generations back · 1980
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K801912 | Arrow Positive Placement Con/Epidural an | Arrow Intl., Inc. | 1980 | Class I |
| −1 | K021567 | Stimucath Continuous Nerve Block Set, Product Number AB-05000 | Arrow Intl., Inc. | 2002 | 2 |
| 0 (this device) | K060186 | Polyplex Stimulating Catheter System | Te ME NA Sas | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1984 | 1 | 0 |
| 2001 | 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.
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.
Top candidate predicates for a new CAZ device
- #1 K261372 Profoject™ LOR Syringescore 12.4 · 2 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 |
|---|---|---|---|
| * | K991259 | TE ME NA Epidural CatheterSummary page 1…th the necessary accessories required to perform the procedure and fix the catheter in place. Predicate Device: Te me na - Polymedic Epidural Anesthesia Catheter K991259 Arrow International - StimuCath Continuous Nerve Block Set K021567 Substantial Equivalence: Te me na claims the proposed dev… | 2001 |
| * | K021567 | Stimucath Continuous Nerve Block Set, Product Number AB-05000Summary page 1…the catheter in place. Predicate Device: Te me na - Polymedic Epidural Anesthesia Catheter K991259 Arrow International - StimuCath Continuous Nerve Block Set K021567 Substantial Equivalence: Te me na claims the proposed device system to be substantially equivalent to the devices previously cl… | 2002 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
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.
- K801912Arrow Positive Placement Con/Epidural anArrow Intl., Inc. · 1980 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 26 years and passes through 2 companies; a new generation was cleared every 21.8 years on median.
- 2 of the 5 ancestors have a recall of any class; 1 has a Class I recall.
How does its category compare?
All CAZ devicesCAZ Anesthesia Conduction Kit: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CAZ
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · CAZ
108in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CAZ
1in 2024
Class I (11 since 2007) Class II/III not classified
Adverse event reports per year · CAZ
137in 2025
MAUDE reports naming product code CAZ, 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 | 4 | 172 | 0 | 81 |
| 2008 | 4 | 99 | 0 | 80 |
| 2009 | 2 | — | 29 | 134 |
| 2010 | 2 | — | 8 | 139 |
| 2011 | 1 | — | 2 | 187 |
| 2012 | 9 | 108 | 0 | 187 |
| 2013 | 0 | — | 12 | 276 |
| 2014 | 0 | — | 2 | 251 |
| 2015 | 1 | — | 1 | 235 |
| 2016 | 2 | — | 1 | 372 |
| 2017 | 0 | — | 0 | 353 |
| 2018 | 0 | — | 0 | 448 |
| 2019 | 1 | — | 0 | 472 |
| 2020 | 1 | — | 0 | 274 |
| 2021 | 1 | — | 0 | 165 |
| 2022 | 1 | — | 0 | 270 |
| 2023 | 1 | — | 0 | 60 |
| 2024 | 0 | — | 1 | 165 |
| 2025 | 0 | — | 0 | 137 |
| 2026 | 1 | — | 12 (11) | — |
What is it indicated for?
The Te me na POLYPLEX Stimulating Catheter System is intended for placement of
catheters next to nerves and nerve plexuses for continuous nerve block anesthesia or
analgesia techniques for periods not exceeding 72 hours.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060186 · printed Nov 5, 2026
Cite this page
510(k) Report. “K060186: Polyplex Stimulating Catheter System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K060186
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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