510(k) · Cleared
Recalled · Class I · 2026Arrow Flexblock Continuous Peripheral Nerve Block Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arrow International, Inc. · CAZ Anesthesia Conduction Kit
Cleared on Aug 28, 2012 as substantially equivalent to K103658 (Teleflex, Inc., 2012) and 1 other predicate after a 48-day review. Its family tree reaches back 4 generations to 1980. 5 of the 12 devices in its family, counting itself, have a Class I recall. 2 later devices descend from it. It has been recalled once, including a Class I recall.
- Decided
- Aug 28, 2012
- Review
- 48 days
- Class
- Class II
- Product code
- CAZ
- Recalls
- 1 (1 Class I)
- Predicates
- 2
Its longest line of descent runs back 4 generations to K801912 (1980). 9 ancestors in all. 2 later devices descend from it, 2 citing it directly. 5 of the 12 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK801912 Arrow Positive Placement Con/Epidural anArrow Intl., Inc. · 1980 · Recalled (Class I)
- 3 generations backK021567 Stimucath Continuous Nerve Block Set, Product Number AB-05000Arrow Intl., Inc. · 2002 · Recalled
- 2 generations backK030937 Stimucath Continuous Nerve Block Set, Models AB-02030, AB-02060…Arrow International, Inc. · 2003 · Recalled
- 1 generation backK121403 Continuous Peripheral Nerve Block Catheter Kit and SetTeleflex, Inc. · 2012 · Recalled (Class I)
- This deviceK122027 Arrow Flexblock Continuous Peripheral Nerve Block CatheterArrow International, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK153652 ARROW FlexBlock Continuous Peripheral Nerve Block Catheter Kit/SetTeleflex, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK133316 Spirol Block (19 GA. Open End Models), (20 GA. Open End Models), (19…Epimed International, Inc. · 2014
Class I recalls in this family
- K121403 Continuous Peripheral Nerve Block Catheter Kit…direct predicate · 2012
- K103658 Flextip Plus Closed Tip Epidural Catherterdirect predicate · 2012
- K884552 Continuous Epidural Anesthesia Kit W/Poly Catheter2 generations back · 1989
- K801912 Arrow Positive Placement Con/Epidural an4 generations back · 1980
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K801912 | Arrow Positive Placement Con/Epidural an | Arrow Intl., Inc. | 1980 | Class I |
| −3 | 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 |
| −1 | K121403 | Continuous Peripheral Nerve Block Catheter Kit and Set | Teleflex, Inc. | 2012 | Class I |
| 0 (this device) | K122027 | Arrow Flexblock Continuous Peripheral Nerve Block Catheter | Arrow International, Inc. | 2012 | — |
| +1 | K153652 | ARROW FlexBlock Continuous Peripheral Nerve Block Catheter Kit/Set | Teleflex, Inc. | 2016 | — |
| +1 | K133316 | Spirol Block (19 GA. Open End Models), (20 GA. Open End Models), (19 GA.… | Epimed International, Inc. | 2014 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 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.
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? (2)
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 |
|---|---|---|---|
| * | K103658 | Flextip Plus Closed Tip Epidural CatherterSummary page 1…68.5140; Anesthesia Conduction Catheter, BSO, 868.5120 Predicate Device The primary predicate device is Arrow's FlexTip Pius Closed Tip Epidural (K103658). The Continuous Peripheral Nerve Block Catheter (K121403) is the reference predicate. Device Description The ARROW FlexBlock C… | 2012 |
| * | K121403 | Continuous Peripheral Nerve Block Catheter Kit and SetSummary page 1…er, BSO, 868.5120 Predicate Device The primary predicate device is Arrow's FlexTip Pius Closed Tip Epidural (K103658). The Continuous Peripheral Nerve Block Catheter (K121403) is the reference predicate. Device Description The ARROW FlexBlock Continuous Peripheral Nerve Block Catheter has the followin… | 2012 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (5 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… |
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 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
- K103658Flextip Plus Closed Tip Epidural CatherterTeleflex, Inc. · 2012 · Direct predicate · ◆ in the 2012 ancestors bar of FIG. 11 Class I recall
- K884552Continuous Epidural Anesthesia Kit W/Poly CatheterArrow Intl., Inc. · 1989 · 2 generations back · ◆ in the 1989 ancestors bar of FIG. 11 Class I recall
- K801912Arrow Positive Placement Con/Epidural anArrow Intl., Inc. · 1980 · 4 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 32 years and passes through 3 companies; a new generation was cleared every 9.2 years on median.
- 6 of the 9 ancestors have a recall of any class; 4 have a Class I recall.
- Of its descendants, K153652 (Teleflex, Inc., 2016) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K103658.
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 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 as stated in the FDA summary.
https://510kreport.com/device/K122027 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122027: Arrow Flexblock Continuous Peripheral Nerve Block Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122027
Report an extraction error
Are you the manufacturer?
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