510(k) · Cleared
Recalled · Class I · 2026Arrow Positive Placement Con/Epidural an
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arrow Intl., Inc. · CAZ Anesthesia Conduction Kit
Cleared on Sep 16, 1980 after a 36-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 of the 47 devices in its family, counting itself, have a Class I recall. 46 later devices descend from it. It has been recalled 10 times, including a Class I recall.
- Decided
- Sep 16, 1980
- Review
- 36 days
- Class
- Class II
- Product code
- CAZ
- Recalls
- 10 (1 Class I)
- Predicates
- 0
46 later devices descend from it, 2 citing it directly. 3 of the 47 devices in this family, counting this one, have a Class I recall.
- This deviceK801912 Arrow Positive Placement Con/Epidural anArrow Intl., Inc. · 1980
- Descendant · cites it directly · 32 of its ownK021567 Stimucath Continuous Nerve Block Set, Product Number AB-05000Arrow Intl., Inc. · 2002 · Recalled
- Descendant · 2 generations on · 29 of its ownK030937 Stimucath Continuous Nerve Block Set, Models AB-02030, AB-02060…Arrow International, Inc. · 2003 · Recalled
- Descendant · 3 generations on · 23 of its ownK033018 Stimulong Plus Catheter Set Model, VariousPajunk GmbH · 2004
- Descendant · 3 generations on · 13 of its ownK063282 Contiplex Stim Continuous Nerve Block SetB.Braun Medical, Inc. · 2007
- Descendant · 4 generations on · 12 of its ownK090995 B. Braun Contiplex Continuous Nerve Block SetB.Braun Medical, Inc. · 2009
Showing 5 of 46 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 46 · See all- K021567Stimucath Continuous Nerve Block Set, Product Number AB-05000Arrow Intl., Inc. · 2002 · cites it directly32descendants
- K030937Stimucath Continuous Nerve Block Set, Models AB-02030, AB-02060, AB-02090, AB-02030-PK…Arrow International, Inc. · 2003 · 2 generations on29descendants
- K033018Stimulong Plus Catheter Set Model, VariousPajunk GmbH · 2004 · 3 generations on23descendants
- K063282Contiplex Stim Continuous Nerve Block SetB.Braun Medical, Inc. · 2007 · 3 generations on13descendants
- K090995B. Braun Contiplex Continuous Nerve Block SetB.Braun Medical, Inc. · 2009 · 4 generations on12descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K801912 | Arrow Positive Placement Con/Epidural an | Arrow Intl., Inc. | 1980 | — |
| +1 | K021567 | Stimucath Continuous Nerve Block Set, Product Number AB-05000 | Arrow Intl., Inc. | 2002 | 2 |
| +2 | K030937 | Stimucath Continuous Nerve Block Set, Models AB-02030, AB-02060, AB-02090… | Arrow International, Inc. | 2003 | 1 |
| +3 | K033018 | Stimulong Plus Catheter Set Model, Various | Pajunk GmbH | 2004 | — |
| +3 | K063282 | Contiplex Stim Continuous Nerve Block Set | B.Braun Medical, Inc. | 2007 | — |
| +4 | K090995 | B. Braun Contiplex Continuous Nerve Block Set | B.Braun Medical, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 3 | 0 |
| 2004 | 4 | 0 |
| 2005 | 2 | 0 |
| 2006 | 4 | 0 |
| 2007 | 3 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 5 | 2 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 4 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2020 | 3 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (46)
See all 462 later devices cite it directly; ranked here by how many devices descend from each in turn.
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… |
| Jul 6, 2020 | Class II | Z-2803-2020 | 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… |
| Jan 15, 2020 | Class II | Z-1175-2020 | Other | There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch. |
| Dec 20, 2019 | Class II | Z-1249-2020 | Incorrect or no expiration date | Product lidstock contains the incorrect expiration date for the product |
| Dec 20, 2019 | Class II | Z-1246-2020 | Incorrect or no expiration date | Product lidstock contains the incorrect expiration date for the product |
| Dec 20, 2019 | Class II | Z-1251-2020 | Incorrect or no expiration date | Product lidstock contains the incorrect expiration date for the product |
| Dec 20, 2019 | Class II | Z-1248-2020 | Incorrect or no expiration date | Product lidstock contains the incorrect expiration date for the product |
| Dec 20, 2019 | Class II | Z-1245-2020 | Incorrect or no expiration date | Product lidstock contains the incorrect expiration date for the product |
| Dec 20, 2019 | Class II | Z-1247-2020 | Incorrect or no expiration date | Product lidstock contains the incorrect expiration date for the product |
| Apr 11, 2018 | Class II | Z-2012-2018 | Under Investigation by firm | Product sterility may be compromised due to unsealed packaging. |
The 5 latest of 10 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.
- K121403Continuous Peripheral Nerve Block Catheter Kit and SetTeleflex, Inc. · 2012 · 3 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
- K122027Arrow Flexblock Continuous Peripheral Nerve Block CatheterArrow International, Inc. · 2012 · 4 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K021567 (Arrow Intl., Inc., 2002) has gone furthest, with 32 descendants of its own.
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) | — |
https://510kreport.com/device/K801912 · printed Nov 4, 2026
Cite this page
510(k) Report. “K801912: Arrow Positive Placement Con/Epidural an.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K801912
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026