510(k) · Cleared
Recalled · Class I · 2026Continuous Epidural Anesthesia Kit W/Poly Catheter
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 Mar 14, 1989 after a 134-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 of the 10 devices in its family, counting itself, have a Class I recall. 9 later devices descend from it. It has been recalled 8 times, including a Class I recall.
- Decided
- Mar 14, 1989
- Review
- 134 days
- Class
- Class II
- Product code
- CAZ
- Recalls
- 8 (1 Class I)
- Predicates
- 0
9 later devices descend from it, 1 citing it directly. 4 of the 10 devices in this family, counting this one, have a Class I recall.
- This deviceK884552 Continuous Epidural Anesthesia Kit W/Poly CatheterArrow Intl., Inc. · 1989
- Descendant · cites it directly · 8 of its ownK103658 Flextip Plus Closed Tip Epidural CatherterTeleflex, Inc. · 2012 · Recalled (Class I)
- Descendant · 2 generations on · 2 of its ownK122027 Arrow Flexblock Continuous Peripheral Nerve Block CatheterArrow International, Inc. · 2012 · Recalled (Class I)
- Descendant · 2 generations on · 1 of its ownK143581 Arrow Epidural Catheter KitTeleflexmedical, Inc. · 2015
- Descendant · 2 generations on · 1 of its ownK140110 Flextip Plus Epidural Catheter;Flexblock Continous Peripheral Nerve…Teleflex, Inc. · 2015 · Recalled (Class I)
- Descendant · 2 generations on · 0 of its ownK230603 Arrow Non-Stimulating SnapLock Adapter (K-05520-005C); Arrow…Teleflex Medical · 2023
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 9 · See all- K103658Flextip Plus Closed Tip Epidural CatherterTeleflex, Inc. · 2012 · cites it directly8descendants
- K122027Arrow Flexblock Continuous Peripheral Nerve Block CatheterArrow International, Inc. · 2012 · 2 generations on2descendants
- K143581Arrow Epidural Catheter KitTeleflexmedical, Inc. · 2015 · 2 generations on1descendant
- K140110Flextip Plus Epidural Catheter;Flexblock Continous Peripheral Nerve Block Catheter Kit/SetTeleflex, Inc. · 2015 · 2 generations on1descendant
- K230603Arrow Non-Stimulating SnapLock Adapter (K-05520-005C); Arrow Non-Stimulating Next Gen…Teleflex Medical · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K884552 | Continuous Epidural Anesthesia Kit W/Poly Catheter | Arrow Intl., Inc. | 1989 | — |
| +1 | K103658 | Flextip Plus Closed Tip Epidural Catherter | Teleflex, Inc. | 2012 | Class I |
| +2 | K122027 | Arrow Flexblock Continuous Peripheral Nerve Block Catheter | Arrow International, Inc. | 2012 | Class I |
| +2 | K143581 | Arrow Epidural Catheter Kit | Teleflexmedical, Inc. | 2015 | — |
| +2 | K140110 | Flextip Plus Epidural Catheter;Flexblock Continous Peripheral Nerve Block… | Teleflex, Inc. | 2015 | Class I |
| +2 | K230603 | Arrow Non-Stimulating SnapLock Adapter (K-05520-005C); Arrow Non-Stimulating… | Teleflex Medical | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 2 |
| 2014 | 1 | 0 |
| 2015 | 2 | 1 |
| 2016 | 2 | 0 |
| 2019 | 1 | 0 |
| 2023 | 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.
4 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? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K103658 | Flextip Plus Closed Tip Epidural Catherter Class I | 2012 | 8 |
Has anything in its family been recalled? (4 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-1252-2020 | Incorrect or no expiration date | Product lidstock contains the incorrect expiration date for the product |
| Dec 20, 2019 | Class II | Z-1244-2020 | Incorrect or no expiration date | Product lidstock contains the incorrect expiration date for the product |
| Apr 11, 2018 | Class II | Z-2013-2018 | Under Investigation by firm | Product sterility may be compromised due to unsealed packaging. |
| Apr 11, 2018 | Class II | Z-1957-2018 | Under Investigation by firm | Product sterility may be compromised due to unsealed packaging. |
| Apr 11, 2018 | Class II | Z-1961-2018 | Under Investigation by firm | Product sterility may be compromised due to unsealed packaging. |
| Jan 5, 2015 | Class II | Z-1080-2015 | Labeling design | The product labeling does not specify the 5 year shelf life of the product. |
| Nov 11, 2010 | Not classified | Z-1012-2011 | Employee error | Sterility may be compromised. |
The 5 latest of 8 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.
- K103658Flextip Plus Closed Tip Epidural CatherterTeleflex, Inc. · 2012 · Cites it directly · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
- K122027Arrow Flexblock Continuous Peripheral Nerve Block CatheterArrow International, Inc. · 2012 · 2 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
- K140110Flextip Plus Epidural Catheter;Flexblock Continous Peripheral Nerve Block Catheter Kit/SetTeleflex, Inc. · 2015 · 2 generations on · ◆ in the 2015 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K103658 (Teleflex, Inc., 2012) has gone furthest, with 8 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/K884552 · printed Nov 5, 2026
Cite this page
510(k) Report. “K884552: Continuous Epidural Anesthesia Kit W/Poly Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K884552
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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