510(k) · Cleared
Recalled · Class I · 2026Continuous Peripheral Nerve Block Catheter Kit and Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Teleflex, Inc. · CAZ Anesthesia Conduction Kit
Cleared on Jun 20, 2012 as substantially equivalent to K030937 (Arrow International, Inc., 2003) after a 41-day review. Its family tree reaches back 3 generations to 1980. 3 of the 10 devices in its family, counting itself, have a Class I recall. 3 later devices descend from it. It has been recalled 7 times, including a Class I recall.
- Decided
- Jun 20, 2012
- Review
- 41 days
- Class
- Class II
- Product code
- CAZ
- Recalls
- 7 (1 Class I)
- Predicates
- 1
Its longest line of descent runs back 3 generations to K801912 (1980). 6 ancestors in all. 3 later devices descend from it, 1 citing it directly. 3 of the 10 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK801912 Arrow Positive Placement Con/Epidural anArrow Intl., Inc. · 1980 · Recalled (Class I)
- 2 generations backK021567 Stimucath Continuous Nerve Block Set, Product Number AB-05000Arrow Intl., Inc. · 2002 · Recalled
- 1 generation backK030937 Stimucath Continuous Nerve Block Set, Models AB-02030, AB-02060…Arrow International, Inc. · 2003 · Recalled
- This deviceK121403 Continuous Peripheral Nerve Block Catheter Kit and SetTeleflex, Inc. · 2012
- Descendant · cites it directly · 2 of its ownK122027 Arrow Flexblock Continuous Peripheral Nerve Block CatheterArrow International, Inc. · 2012 · Recalled (Class I)
- Descendant · 2 generations on · 0 of its ownK153652 ARROW FlexBlock Continuous Peripheral Nerve Block Catheter Kit/SetTeleflex, Inc. · 2016
- Descendant · 2 generations on · 0 of its ownK133316 Spirol Block (19 GA. Open End Models), (20 GA. Open End Models), (19…Epimed International, Inc. · 2014
Class I recalls in this family
Most influential descendants
Showing 3 of 3 · See all- K122027Arrow Flexblock Continuous Peripheral Nerve Block CatheterArrow International, Inc. · 2012 · cites it directly2descendants
- K153652ARROW FlexBlock Continuous Peripheral Nerve Block Catheter Kit/SetTeleflex, Inc. · 2016 · 2 generations on0descendants
- K133316Spirol Block (19 GA. Open End Models), (20 GA. Open End Models), (19 GA. Closed End…Epimed International, Inc. · 2014 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K801912 | Arrow Positive Placement Con/Epidural an | Arrow Intl., Inc. | 1980 | Class I |
| −2 | K021567 | Stimucath Continuous Nerve Block Set, Product Number AB-05000 | Arrow Intl., Inc. | 2002 | 2 |
| −1 | K030937 | Stimucath Continuous Nerve Block Set, Models AB-02030, AB-02060, AB-02090… | Arrow International, Inc. | 2003 | 1 |
| 0 (this device) | K121403 | Continuous Peripheral Nerve Block Catheter Kit and Set | Teleflex, Inc. | 2012 | — |
| +1 | K122027 | Arrow Flexblock Continuous Peripheral Nerve Block Catheter | Arrow International, Inc. | 2012 | Class I |
| +2 | K153652 | ARROW FlexBlock Continuous Peripheral Nerve Block Catheter Kit/Set | Teleflex, Inc. | 2016 | — |
| +2 | K133316 | Spirol Block (19 GA. Open End Models), (20 GA. Open End Models), (19 GA.… | Epimed International, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1984 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 1 |
| 2014 | 1 | 0 |
| 2016 | 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.
3 devices in this family have 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? (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 |
|---|---|---|---|
| * | K030937 | Stimucath Continuous Nerve Block Set, Models AB-02030, AB-02060, AB-02090, AB-02030-PK…Summary page 1…CER 868-5140 - anesthetic conduction kit Class 2 Predicate Devices: Arrow - StimuCathTM - K030937 Device Description: The Arrow Continuous Peripheral Nerve Block Catheter set and kit is comprised of components and accessories… | 2003 |
| † | K021567 | Stimucath Continuous Nerve Block Set, Product Number AB-05000 | 2002 |
| † | K001587 | 19 GA Plastic Reinforced Epidural Catheter | 2000 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K122027 | Arrow Flexblock Continuous Peripheral Nerve Block Catheter Class I | 2012 | 2 |
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 21, 2026 | Class I | Z-2364-2026 | Nonconforming Material/Component | Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a… |
| Dec 20, 2019 | Class II | Z-1239-2020 | Incorrect or no expiration date | Product lidstock contains the incorrect expiration date for the product |
| Dec 20, 2019 | Class II | Z-1253-2020 | Incorrect or no expiration date | Product lidstock contains the incorrect expiration date for the product |
| Dec 20, 2019 | Class II | Z-1241-2020 | Incorrect or no expiration date | Product lidstock contains the incorrect expiration date for the product |
| Apr 11, 2018 | Class II | Z-1958-2018 | Under Investigation by firm | Product sterility may be compromised due to unsealed packaging. |
| Nov 10, 2014 | Class II | Z-0573-2015 | Labeling False and Misleading | Arrow is recalling certain lots of the Continuous Nerve Block Component, Product Code: AB-18040-N, due to a labeling inconsistency. The product lidstock incorrectly identifies the needle in the finished good as 17Ga rather than the… |
| Oct 9, 2013 | Class II | Z-0546-2014 | Labeling mix-ups | A labeling inconsistency was discovered in which the lidstock states that the kit contains a stimulator cable with 1.5mm socket, however, the kit contains a stimulator cable with 1.5mm pin. |
The 5 latest of 7 recalls; the web page lists all.
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 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K122027Arrow Flexblock Continuous Peripheral Nerve Block CatheterArrow International, Inc. · 2012 · Cites it directly · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 32 years and passes through 3 companies; a new generation was cleared every 9.2 years on median.
- 3 of the 6 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K122027 (Arrow International, Inc., 2012) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K030937.
How does its category compare?
All CAZ devicesCAZ Anesthesia Conduction Kit: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
Continuous nerve block kit and set permits 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K121403 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121403: Continuous Peripheral Nerve Block Catheter Kit and Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121403
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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