510(k) · Cleared
ClearedE-Cath STIM acc. Tsui
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
PAJUNK GmbH Medizintechnologie · CAZ Anesthesia Conduction Kit
Cleared on Dec 29, 2020 as substantially equivalent to K152952 (PAJUNK GmbH Medizintechnologie, 2016) and 1 other predicate after a 104-day review. Its family tree reaches back 7 generations to 1981. 1 of the 21 devices in its family, counting itself, has a Class I recall.
- Decided
- Dec 29, 2020
- Review
- 104 days
- Class
- Class II
- Product code
- CAZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K813186 (1981). 20 ancestors in all, the oldest K801912 (1980). No later device cites it as a predicate yet. 1 of the 21 devices in this family, counting this one, has a Class I recall.
- Root · 7 generations backK813186 Perfix Set for Epidural Anesthesia W/TuoBurron Medical Products, Inc. · 1981
- 6 generations backK991543 Intraop CatheterI-Flow Corp. · 1999
- 5 generations backK994374 Soaker CatheterI-Flow Corp. · 2000
- 4 generations backK022869 Soaker CatheterI-Flow Corp. · 2002
- 3 generations backK043456 Modification to Soaker CatheterI-Flow Corp. · 2005
- 2 generations backK143164 ON-Q Pain Relief System, QuikBloc Over-the-Needle Catheter SetKimberly-Clark Corporation · 2014
- 1 generation backK152952 E-CathPAJUNK GmbH Medizintechnologie · 2016
- This deviceK202699 E-Cath STIM acc. TsuiPAJUNK GmbH Medizintechnologie · 2020
Class I recalls in this family
- K801912 Arrow Positive Placement Con/Epidural an4 generations back · 1980
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K813186 | Perfix Set for Epidural Anesthesia W/Tuo | Burron Medical Products, Inc. | 1981 | — |
| −6 | K991543 | Intraop Catheter | I-Flow Corp. | 1999 | — |
| −5 | K994374 | Soaker Catheter | I-Flow Corp. | 2000 | — |
| −4 | K022869 | Soaker Catheter | I-Flow Corp. | 2002 | — |
| −3 | K043456 | Modification to Soaker Catheter | I-Flow Corp. | 2005 | — |
| −2 | K143164 | ON-Q Pain Relief System, QuikBloc Over-the-Needle Catheter Set | Kimberly-Clark Corporation | 2014 | — |
| −1 | K152952 | E-Cath | PAJUNK GmbH Medizintechnologie | 2016 | — |
| 0 (this device) | K202699 | E-Cath STIM acc. Tsui | PAJUNK GmbH Medizintechnologie | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 1 |
| 1983 | 1 | 0 |
| 1984 | 2 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2011 | 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 |
|---|---|---|---|
| * | K152952 | E-CathSummary page 5…latory Class: II Panel: Anesthesiology Predicate Device: K152952 E-Cath Second Predicate Device: K033018 StimuLong 510(k) E-Cath acc. Tsui… | 2016 |
| * | K033018 | Stimulong Plus Catheter Set Model, VariousSummary page 5…Anesthesiology Predicate Device: K152952 E-Cath Second Predicate Device: K033018 StimuLong 510(k) E-Cath acc. Tsui 2020-12-27 R&D Resp. SAS… | 2004 |
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 · 4 generations back · ◆ in the 1980 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 39 years and passes through 4 companies; a new generation was cleared every 2.5 years on median.
- 4 of the 20 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. 2020, this device’s year, is highlighted.
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 E-Cath STIM acc. Tsui System is indicated for delivery of medication for regional anesthesia and pain management. Route of administration may be intraoperative, percutaneous, or perineural. To assist the physician pinpoint the area of application an electrical stimulus can be applied to the conduction needle. After needle removal, to assist the physician pinpoint conduction catheter placement, an electrical stimulus can be applied to the conduction catheter tip via the catheter adapter.
The E-Cath STIM acc. Tsui System is contraindicated for the epidural space.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K202699 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202699: E-Cath STIM acc. Tsui.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202699
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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