510(k) · Cleared
Recalled · Class I · 2026Flextip Plus Closed Tip Epidural Catherter
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 May 16, 2012 as substantially equivalent to K884552 (Arrow Intl., Inc., 1989) after a 518-day review. Its family tree reaches back 1 generation to 1989. 4 of the 10 devices in its family, counting itself, have a Class I recall. 8 later devices descend from it. It has been recalled 4 times, including a Class I recall.
- Decided
- May 16, 2012
- Review
- 518 days
- Class
- Class II
- Product code
- CAZ
- Recalls
- 4 (1 Class I)
- Predicates
- 1
Its longest line of descent runs back 1 generation to K884552 (1989). 8 later devices descend from it, 4 citing it directly. 4 of the 10 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK884552 Continuous Epidural Anesthesia Kit W/Poly CatheterArrow Intl., Inc. · 1989 · Recalled (Class I)
- This deviceK103658 Flextip Plus Closed Tip Epidural CatherterTeleflex, Inc. · 2012
- Descendant · cites it directly · 2 of its ownK122027 Arrow Flexblock Continuous Peripheral Nerve Block CatheterArrow International, Inc. · 2012 · Recalled (Class I)
- Descendant · cites it directly · 1 of its ownK143581 Arrow Epidural Catheter KitTeleflexmedical, Inc. · 2015
- Descendant · cites it directly · 1 of its ownK140110 Flextip Plus Epidural Catheter;Flexblock Continous Peripheral Nerve…Teleflex, Inc. · 2015 · Recalled (Class I)
- Descendant · cites it directly · 0 of its ownK230603 Arrow Non-Stimulating SnapLock Adapter (K-05520-005C); Arrow…Teleflex Medical · 2023
- Descendant · 2 generations on · 0 of its ownK181782 Medline Reinforced Epidural CatheterMedline Industries, Inc. · 2019
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 8 · See all- K122027Arrow Flexblock Continuous Peripheral Nerve Block CatheterArrow International, Inc. · 2012 · cites it directly2descendants
- K143581Arrow Epidural Catheter KitTeleflexmedical, Inc. · 2015 · cites it directly1descendant
- K140110Flextip Plus Epidural Catheter;Flexblock Continous Peripheral Nerve Block Catheter Kit/SetTeleflex, Inc. · 2015 · cites it directly1descendant
- K230603Arrow Non-Stimulating SnapLock Adapter (K-05520-005C); Arrow Non-Stimulating Next Gen…Teleflex Medical · 2023 · cites it directly0descendants
- K181782Medline Reinforced Epidural CatheterMedline Industries, Inc. · 2019 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K884552 | Continuous Epidural Anesthesia Kit W/Poly Catheter | Arrow Intl., Inc. | 1989 | Class I |
| 0 (this device) | K103658 | Flextip Plus Closed Tip Epidural Catherter | Teleflex, Inc. | 2012 | — |
| +1 | K122027 | Arrow Flexblock Continuous Peripheral Nerve Block Catheter | Arrow International, Inc. | 2012 | Class I |
| +1 | K143581 | Arrow Epidural Catheter Kit | Teleflexmedical, Inc. | 2015 | — |
| +1 | K140110 | Flextip Plus Epidural Catheter;Flexblock Continous Peripheral Nerve Block… | Teleflex, Inc. | 2015 | Class I |
| +1 | K230603 | Arrow Non-Stimulating SnapLock Adapter (K-05520-005C); Arrow Non-Stimulating… | Teleflex Medical | 2023 | — |
| +2 | K181782 | Medline Reinforced Epidural Catheter | Medline Industries, Inc. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 1 |
| 2014 | 1 | 0 |
| 2015 | 2 | 1 |
| 2016 | 2 | 0 |
| 2019 | 1 | 0 |
| 2023 | 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.
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? (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 |
|---|---|---|---|
| * | K884552 | Continuous Epidural Anesthesia Kit W/Poly CatheterSummary page 1…Conduction Catheter, BSO, 868.5120 Predicate Device The predicate device is Arrow's Continuous Epidural Anesthesia kit with polyurethane catheter, K884552 Device Description The FlexTip Plus Epidural Catheter has the following characteristics: * 19 Ga. single lumen 900 mm * A… | 1989 |
What descends from it? (8)
4 later devices cite 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 |
| K143581 | Arrow Epidural Catheter Kit | 2015 | 1 |
| K140110 | Flextip Plus Epidural Catheter;Flexblock Continous Peripheral Nerve Block Catheter Kit/Set Class I | 2015 | 1 |
| K230603 | Arrow Non-Stimulating SnapLock Adapter (K-05520-005C); Arrow Non-Stimulating Next Gen… | 2023 | 0 |
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… |
| Jan 15, 2020 | Class II | Z-1179-2020 | 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. |
| Apr 11, 2018 | Class II | Z-1962-2018 | Under Investigation by firm | Product sterility may be compromised due to unsealed packaging. |
| Jul 30, 2015 | Class II | Z-2462-2015 | Unknown/Undetermined by firm | the catheter peel-away component hub tabs may prematurely detach. One injury reported. |
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.
- K884552Continuous Epidural Anesthesia Kit W/Poly CatheterArrow Intl., Inc. · 1989 · Direct predicate · ◆ 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
- K140110Flextip Plus Epidural Catheter;Flexblock Continous Peripheral Nerve Block Catheter Kit/SetTeleflex, Inc. · 2015 · Cites it directly · ◆ in the 2015 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Its one ancestor has a recall, Class I.
- Of its descendants, K122027 (Arrow International, Inc., 2012) has gone furthest, with 2 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. 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?
The Arrow Epidural Catheter permits access to the epidural space for the administration of epidural anesthetic. The epidural catheter is intended for use up to 72 hours.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103658 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103658: Flextip Plus Closed Tip Epidural Catherter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103658
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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