510(k) · Cleared
ClearedPerfix Set for Epidural Anesthesia W/Tuo
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Burron Medical Products, Inc. · CAZ Anesthesia Conduction Kit
Cleared on Dec 3, 1981 after a 17-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 46 later devices descend from it.
- Decided
- Dec 3, 1981
- Review
- 17 days
- Class
- Class II
- Product code
- CAZ
- Recalls
- None
- Predicates
- 0
46 later devices descend from it, 9 citing it directly.
- This deviceK813186 Perfix Set for Epidural Anesthesia W/TuoBurron Medical Products, Inc. · 1981
- Descendant · cites it directly · 31 of its ownK991543 Intraop CatheterI-Flow Corp. · 1999
- Descendant · cites it directly · 18 of its ownK994374 Soaker CatheterI-Flow Corp. · 2000
- Descendant · 2 generations on · 12 of its ownK022869 Soaker CatheterI-Flow Corp. · 2002
- Descendant · cites it directly · 12 of its ownK971233 Soft Tip Epidural Catheter KitB.Braun Medical, Inc. · 1997
- Descendant · 2 generations on · 11 of its ownK043456 Modification to Soaker CatheterI-Flow Corp. · 2005
Showing 5 of 46 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 46 · See all- K991543Intraop CatheterI-Flow Corp. · 1999 · cites it directly31descendants
- K994374Soaker CatheterI-Flow Corp. · 2000 · cites it directly18descendants
- K022869Soaker CatheterI-Flow Corp. · 2002 · 2 generations on12descendants
- K971233Soft Tip Epidural Catheter KitB.Braun Medical, Inc. · 1997 · cites it directly12descendants
- K043456Modification to Soaker CatheterI-Flow Corp. · 2005 · 2 generations on11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K813186 | Perfix Set for Epidural Anesthesia W/Tuo | Burron Medical Products, Inc. | 1981 | — |
| +1 | K991543 | Intraop Catheter | I-Flow Corp. | 1999 | — |
| +1 | K994374 | Soaker Catheter | I-Flow Corp. | 2000 | — |
| +2 | K022869 | Soaker Catheter | I-Flow Corp. | 2002 | — |
| +1 | K971233 | Soft Tip Epidural Catheter Kit | B.Braun Medical, Inc. | 1997 | — |
| +2 | K043456 | Modification to Soaker Catheter | I-Flow Corp. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 5 | 0 |
| 2005 | 4 | 0 |
| 2006 | 6 | 0 |
| 2007 | 3 | 0 |
| 2008 | 6 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 4 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (46)
See all 469 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K991543 | Intraop Catheter | 1999 | 31 |
| K994374 | Soaker Catheter | 2000 | 18 |
| K971233 | Soft Tip Epidural Catheter Kit | 1997 | 12 |
| K030830 | B. Braun Nerve Block Catheter | 2003 | 10 |
| K060311 | Epilong Kit for Anesthesiology | 2006 | 5 |
| K013610 | Perifix Safety Epidural Needles | 2002 | 5 |
| K962696 | Perifix Pediatric Epidural Kit | 1997 | 3 |
| K060563 | Epispin, Epispin II Safety, Epispin II, Epispin I, Epispin IV | 2006 | 1 |
| K994275 | Sims Portex Anesthesia Catheter | 2000 | 1 |
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?
- Of its descendants, K991543 (I-Flow Corp., 1999) has gone furthest, with 31 descendants of its own.
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) | — |
https://510kreport.com/device/K813186 · printed Nov 6, 2026
Cite this page
510(k) Report. “K813186: Perfix Set for Epidural Anesthesia W/Tuo.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K813186
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026