510(k) · Cleared
ClearedPandin Continuous Nerve Stimulating Catheter, Models 561-18-05, 561-18-09, 561-18-15, 562-18-05, 562-18-09 & 562-18-15
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hdc Corp. · CAZ Anesthesia Conduction Kit
Cleared on Sep 9, 2003 as substantially equivalent to K021567 (Arrow Intl., Inc., 2002) and 2 other predicates after a 386-day review. Its family tree reaches back 2 generations to 1980. 1 of the 6 devices in its family, counting itself, has a Class I recall.
- Decided
- Sep 9, 2003
- Review
- 386 days
- Class
- Class II
- Product code
- CAZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K801912 (1980). 5 ancestors in all. No later device cites it as a predicate yet. 1 of the 6 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK801912 Arrow Positive Placement Con/Epidural anArrow Intl., Inc. · 1980 · Recalled (Class I)
- 1 generation backK021567 Stimucath Continuous Nerve Block Set, Product Number AB-05000Arrow Intl., Inc. · 2002 · Recalled
- This deviceK022752 Pandin Continuous Nerve Stimulating Catheter, Models 561-18-05…Hdc Corp. · 2003
Class I recalls in this family
- K801912 Arrow Positive Placement Con/Epidural an2 generations back · 1980
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K801912 | Arrow Positive Placement Con/Epidural an | Arrow Intl., Inc. | 1980 | Class I |
| −1 | K021567 | Stimucath Continuous Nerve Block Set, Product Number AB-05000 | Arrow Intl., Inc. | 2002 | 2 |
| 0 (this device) | K022752 | Pandin Continuous Nerve Stimulating Catheter, Models 561-18-05, 561-18-09… | Hdc Corp. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1984 | 1 | 0 |
| 2000 | 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.
1 device in this family has 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? (3)
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 |
|---|---|---|---|
| * | K021567 | Stimucath Continuous Nerve Block Set, Product Number AB-05000 | 2002 |
| * | K994059 | Cla Kit (Continuous Local Anesthesia), Model 551-17, 551-10, 551-07Summary page 1…h Continuous Nerve CLA Kit (Nerve Neurotrac Block Set Block Infusion) (Neuro-Trace) KO2 1567 K994059 K831715 Intended Use: The Pandin Continuous Nerve Stimulating Catheter permits placement of catheter… | 2000 |
| * | K831715 | NeurotracSummary page 1…CLA Kit (Nerve Neurotrac Block Set Block Infusion) (Neuro-Trace) KO2 1567 K994059 K831715 Intended Use: The Pandin Continuous Nerve Stimulating Catheter permits placement of catheters next to nerves and ne… | 1983 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 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.
- K801912Arrow Positive Placement Con/Epidural anArrow Intl., Inc. · 1980 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 23 years and passes through 2 companies; a new generation was cleared every 21.8 years on median.
- 2 of the 5 ancestors have a recall of any class; 1 has a Class I recall.
- 2 other devices also cite its predicate K021567.
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) | — |
What is it indicated for?
The Pandin Continuous Nerve Stimulating Catheter permits placement of catheters next to nerves and nerve plexus for continuous nerve block anesthesia or analgesia techniques. It is indicated for use up to 72 hours.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022752 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022752: Pandin Continuous Nerve Stimulating Catheter, Models 561-18-05, 561-18-09, 561-18-15, 562-18-05, 562-18-09 & 562-18-15.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022752
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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