510(k) · Cleared
ClearedArrow Epidural Catheter Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Teleflexmedical, Inc. · CAZ Anesthesia Conduction Kit
Cleared on Oct 4, 2016 as substantially equivalent to K143581 (Teleflexmedical, Inc., 2015) after a 169-day review. Its family tree reaches back 3 generations to 1989. 2 of the 5 devices in its family, counting itself, have a Class I recall.
- Decided
- Oct 4, 2016
- Review
- 169 days
- Class
- Class II
- Product code
- CAZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K884552 (1989). 4 ancestors in all. No later device cites it as a predicate yet. 2 of the 5 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK884552 Continuous Epidural Anesthesia Kit W/Poly CatheterArrow Intl., Inc. · 1989 · Recalled (Class I)
- 2 generations backK103658 Flextip Plus Closed Tip Epidural CatherterTeleflex, Inc. · 2012 · Recalled (Class I)
- 1 generation backK143581 Arrow Epidural Catheter KitTeleflexmedical, Inc. · 2015
- This deviceK161075 Arrow Epidural Catheter KitTeleflexmedical, Inc. · 2016
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K884552 | Continuous Epidural Anesthesia Kit W/Poly Catheter | Arrow Intl., Inc. | 1989 | Class I |
| −2 | K103658 | Flextip Plus Closed Tip Epidural Catherter | Teleflex, Inc. | 2012 | Class I |
| −1 | K143581 | Arrow Epidural Catheter Kit | Teleflexmedical, Inc. | 2015 | — |
| 0 (this device) | K161075 | Arrow Epidural Catheter Kit | Teleflexmedical, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 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.
2 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 |
|---|---|---|---|
| * | K143581 | Arrow Epidural Catheter KitSummary page 4…ication Panel: Anesthesiology E. Predicate Device This submission demonstrates substantial equivalence to the predicate device Arrow Epidural Catheter Kit - K143581 F. Device Description The Arrow Epidural Catheter Kit consists of the epidural catheter packaged with various combinations… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (2 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.
What does this lineage say?
- The line of descent spans 27 years and passes through 3 companies; a new generation was cleared every 3.1 years on median.
- 2 of the 4 ancestors have a recall of any class; 2 have 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. 2016, 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 kit permits access to the epidural space for the administration of epidural anesthetic. The epidural catheter kit is intended for use up to 72 hours.
Patient Population: Adult
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161075 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161075: Arrow Epidural Catheter Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161075
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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