510(k) · Cleared
ClearedPerifix Catheter Connector
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
B.Braun Medical, Inc. · BSO Catheter, Conduction, Anesthetic
Cleared on Aug 1, 2002 as substantially equivalent to K840287 (Burron Medical Products, Inc., 1984) after a 42-day review. Its family tree reaches back 1 generation to 1984. 5 later devices descend from it.
- Decided
- Aug 1, 2002
- Review
- 42 days
- Class
- Class II
- Product code
- BSO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K840287 (1984). 5 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK840287 Brachial Plexus Anesthesia TrayBurron Medical Products, Inc. · 1984
- This deviceK022019 Perifix Catheter ConnectorB.Braun Medical, Inc. · 2002
- Descendant · cites it directly · 1 of its ownK033952 Perifix Catheter ConnectorB.Braun Medical, Inc. · 2004 · Recalled
- Descendant · cites it directly · 1 of its ownK032144 Perifix Catheter ConnectorB.Braun Medical, Inc. · 2003 · Recalled
- Descendant · cites it directly · 0 of its ownK172777 Catheter Clamping Adapter LUER 80369-7, Catheter Clamping Adapter…PAJUNK GmbH Medizintechnologie · 2018
- Descendant · 2 generations on · 0 of its ownK051171 Stingray Epidural Catheter ConnectorEpimed International, Inc. · 2005 · Recalled
- Descendant · 2 generations on · 0 of its ownK050557 Amt NanocathAmerican Medical Technologies, Inc. · 2005
Most influential descendants
Showing 5 of 5 · See all- K033952Perifix Catheter ConnectorB.Braun Medical, Inc. · 2004 · cites it directly1descendant
- K032144Perifix Catheter ConnectorB.Braun Medical, Inc. · 2003 · cites it directly1descendant
- K172777Catheter Clamping Adapter LUER 80369-7, Catheter Clamping Adapter NRFit 80369-7PAJUNK GmbH Medizintechnologie · 2018 · cites it directly0descendants
- K051171Stingray Epidural Catheter ConnectorEpimed International, Inc. · 2005 · 2 generations on0descendants
- K050557Amt NanocathAmerican Medical Technologies, Inc. · 2005 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K840287 | Brachial Plexus Anesthesia Tray | Burron Medical Products, Inc. | 1984 | — |
| 0 (this device) | K022019 | Perifix Catheter Connector | B.Braun Medical, Inc. | 2002 | — |
| +1 | K033952 | Perifix Catheter Connector | B.Braun Medical, Inc. | 2004 | 2 |
| +1 | K032144 | Perifix Catheter Connector | B.Braun Medical, Inc. | 2003 | 2 |
| +1 | K172777 | Catheter Clamping Adapter LUER 80369-7, Catheter Clamping Adapter NRFit 80369-7 | PAJUNK GmbH Medizintechnologie | 2018 | — |
| +2 | K051171 | Stingray Epidural Catheter Connector | Epimed International, Inc. | 2005 | 1 |
| +2 | K050557 | Amt Nanocath | American Medical Technologies, Inc. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2018 | 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 BSO? 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 BSO device
- #1 K241410 EDEN ControlCathscore 9.4 · 3 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K840287 | Brachial Plexus Anesthesia TraySummary page 1…Anesthesia Conduction Catheter Kit B. Braun Medical Inc.;Twist Lock Adapter Hub wilh Lucr lock; K840287 (Accu-Bloc Brachial Plexus Anesthesia Tray) KS40179 (Accu-Bloc Epidural Anesthest… | 1984 |
| Kept off the family tree | K840179 | FDA’s K840179 is Continuous Epidural Anesthes. Tray Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 1984 |
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All BSO devicesBSO Catheter, Conduction, Anesthetic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · BSO
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BSO
205in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BSO
2so far in 2026, the most since 2007
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · BSO
139in 2025
MAUDE reports naming product code BSO, 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 | 2 | — | 0 | 18 |
| 2008 | 3 | 155 | 0 | 14 |
| 2009 | 1 | — | 1 | 71 |
| 2010 | 1 | — | 0 | 57 |
| 2011 | 4 | 109 | 0 | 31 |
| 2012 | 0 | — | 0 | 52 |
| 2013 | 1 | — | 0 | 73 |
| 2014 | 2 | — | 0 | 45 |
| 2015 | 1 | — | 0 | 43 |
| 2016 | 5 | 281 | 0 | 71 |
| 2017 | 3 | 205 | 0 | 38 |
| 2018 | 2 | — | 0 | 80 |
| 2019 | 2 | — | 0 | 779 |
| 2020 | 2 | — | 0 | 159 |
| 2021 | 0 | — | 0 | 146 |
| 2022 | 0 | — | 0 | 135 |
| 2023 | 2 | — | 0 | 79 |
| 2024 | 0 | — | 0 | 98 |
| 2025 | 1 | — | 0 | 139 |
| 2026 | 0 | — | 2 (1) | — |
What is it indicated for?
A connection device used to provide various anesthetic and fluid administration devices with a single, common access point to an 18 or 20 gauge Perifix catheter for delivery of anesthetics. The connector is used in conjunction with 18 or 20 gauge Perifix catheters for continuous administration of anesthetic agents.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022019 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022019: Perifix Catheter Connector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022019
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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