510(k) · Cleared
ClearedPerifuse Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smiths Medical Asd, Inc. · CAZ Anesthesia Conduction Kit
Cleared on Aug 2, 2012 as substantially equivalent to K001129 (Life-Tech Intl., Inc., 2000) and 1 other predicate after a 71-day review. Its family tree reaches back 2 generations to 1981.
- Decided
- Aug 2, 2012
- Review
- 71 days
- Class
- Class II
- Product code
- CAZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K813186 (1981). 4 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K813186 | Perfix Set for Epidural Anesthesia W/Tuo | Burron Medical Products, Inc. | 1981 | — |
| −1 | K994275 | Sims Portex Anesthesia Catheter | Sims Portex, Inc. | 2000 | — |
| 0 (this device) | K121525 | Perifuse Catheter | Smiths Medical Asd, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 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.
Planning a device in CAZ? 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 |
|---|---|---|---|
| * | K001129 | Prolong, Models PL50, PL100, PL150Summary page 1…ter Common Name: Anesthesia Conduction Kit Classification Name: Anesthesia Conduction Kit, (21 CER 868.5140, Product Code CAZ) Predicate Device(s): PrimaryPredicate K 001 129, ProLong® Regional Anesthesia Catheter, Model PL5O, PLi 00, PLI50 Secondary Predicate K994275, SIMS Portex An… | 2000 |
| * | K994275 | Sims Portex Anesthesia CatheterSummary page 1…Code CAZ) Predicate Device(s): PrimaryPredicate K 001 129, ProLong® Regional Anesthesia Catheter, Model PL5O, PLi 00, PLI50 Secondary Predicate K994275, SIMS Portex Anesthesia Catheter Reference Device(s): K(033084, Wallace (SureViewTm) Embryo Replacement Catheters & Trial Trans… | 2000 |
| † | K033084 | Wallace (Sure View) Embryo Replacement Catheter and Trial Transfer Catheter | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 31 years and passes through 3 companies; a new generation was cleared every 18.2 years on median.
- 1 of the 4 ancestors has a recall of any class.
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 PeriFuseTM regional anesthesia Catheter is indicated for use during procedures where intermittent administration of local anesthetics is indicated for control of operative, post-operative, acute or chronic pain for peripheral nerve block procedures. The duration of use should not exceed 72 hours.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121525 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121525: Perifuse Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121525
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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