510(k) · Cleared
ClearedARROW FlexBlock Continuous Peripheral Nerve Block Catheter Kit/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 21, 2016 as substantially equivalent to K122027 (Arrow International, Inc., 2012) after a 183-day review. Its family tree reaches back 5 generations to 1980. 5 of the 11 devices in its family, counting itself, have a Class I recall.
- Decided
- Jun 21, 2016
- Review
- 183 days
- Class
- Class II
- Product code
- CAZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K801912 (1980). 10 ancestors in all. No later device cites it as a predicate yet. 5 of the 11 devices in this family, counting this one, have a Class I recall.
- Root · 5 generations backK801912 Arrow Positive Placement Con/Epidural anArrow Intl., Inc. · 1980 · Recalled (Class I)
- 4 generations backK021567 Stimucath Continuous Nerve Block Set, Product Number AB-05000Arrow Intl., Inc. · 2002 · Recalled
- 3 generations backK030937 Stimucath Continuous Nerve Block Set, Models AB-02030, AB-02060…Arrow International, Inc. · 2003 · Recalled
- 2 generations backK121403 Continuous Peripheral Nerve Block Catheter Kit and SetTeleflex, Inc. · 2012 · Recalled (Class I)
- 1 generation backK122027 Arrow Flexblock Continuous Peripheral Nerve Block CatheterArrow International, Inc. · 2012 · Recalled (Class I)
- This deviceK153652 ARROW FlexBlock Continuous Peripheral Nerve Block Catheter Kit/SetTeleflex, Inc. · 2016
Class I recalls in this family
- K122027 Arrow Flexblock Continuous Peripheral Nerve…direct predicate · 2012
- K121403 Continuous Peripheral Nerve Block Catheter Kit…2 generations back · 2012
- K103658 Flextip Plus Closed Tip Epidural Catherter2 generations back · 2012
- K884552 Continuous Epidural Anesthesia Kit W/Poly Catheter3 generations back · 1989
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K801912 | Arrow Positive Placement Con/Epidural an | Arrow Intl., Inc. | 1980 | Class I |
| −4 | K021567 | Stimucath Continuous Nerve Block Set, Product Number AB-05000 | Arrow Intl., Inc. | 2002 | 2 |
| −3 | K030937 | Stimucath Continuous Nerve Block Set, Models AB-02030, AB-02060, AB-02090… | Arrow International, Inc. | 2003 | 1 |
| −2 | K121403 | Continuous Peripheral Nerve Block Catheter Kit and Set | Teleflex, Inc. | 2012 | Class I |
| −1 | K122027 | Arrow Flexblock Continuous Peripheral Nerve Block Catheter | Arrow International, Inc. | 2012 | Class I |
| 0 (this device) | K153652 | ARROW FlexBlock Continuous Peripheral Nerve Block Catheter Kit/Set | Teleflex, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1984 | 1 | 0 |
| 1989 | 1 | 1 |
| 2000 | 1 | 0 |
| 2012 | 1 | 1 |
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.
5 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 |
|---|---|---|---|
| * | K122027 | Arrow Flexblock Continuous Peripheral Nerve Block CatheterSummary page 4…gulation: 21 CFR 868.5140 Class: II Product Code: CAZ – Anesthesia Conduction Kit Predicate Device ARROW FlexBlock Continuous Peripheral Nerve Block Catheter – K122027 Modification and Changes to Predicate The purpose of this 510(k) is to update the MR Conditional statements in the Instructions… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (5 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.
- K122027Arrow Flexblock Continuous Peripheral Nerve Block CatheterArrow International, Inc. · 2012 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
- K121403Continuous Peripheral Nerve Block Catheter Kit and SetTeleflex, Inc. · 2012 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K103658Flextip Plus Closed Tip Epidural CatherterTeleflex, Inc. · 2012 · 2 generations back · ◆ in the 2012 ancestors bar of FIG. 11 Class I recall
- K884552Continuous Epidural Anesthesia Kit W/Poly CatheterArrow Intl., Inc. · 1989 · 3 generations back · ◆ in the 1989 ancestors bar of FIG. 11 Class I recall
- K801912Arrow Positive Placement Con/Epidural anArrow Intl., Inc. · 1980 · 5 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 36 years and passes through 3 companies; a new generation was cleared every 3.8 years on median.
- 7 of the 10 ancestors have a recall of any class; 5 have a Class I recall.
- 1 other device also cites its predicate K122027.
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 FlexBlock Continuous Peripheral Nerve Block Kit/Set permits placement of catheters next to nerves and nerve plexuses for continuous nerve block anesthesia or analgesia techniques including upper extremity, lower extremity, abdominal and paravertebral locations 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/K153652 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153652: ARROW FlexBlock Continuous Peripheral Nerve Block Catheter Kit/Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153652
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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