510(k) Report

510(k) · Cleared

Recalled · Class II · 2018

Perifix Catheter Connector

K032144510(k) TraditionalCleared Oct 1, 200379-day reviewClass II21 CFR 868.5140Recalls 2

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

B.Braun Medical, Inc. · CAZ Anesthesia Conduction Kit

Cleared on Oct 1, 2003 as substantially equivalent to K022019 (B.Braun Medical, Inc., 2002) after a 79-day review. Its family tree reaches back 2 generations to 1984. 1 later device descends from it. It has been recalled 2 times.

Decided
Oct 1, 2003
Review
79 days
Class
Class II
Product code
CAZ
Recalls
2
Predicates
1

Its longest line of descent runs back 2 generations to K840287 (1984). 1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2005: 1 descendant clearedK840287 · Brachial Plexus Anesthesia Tray · Burron Medical Products, Inc. · 1984K022019 · Perifix Catheter Connector · B.Braun Medical, Inc. · 200219801990200020102020
Descendants, by generation 1 generation forward: 1 descendant K022019 · Perifix Catheter Connector · B.Braun Medical, Inc. · 2002K840287 · Brachial Plexus Anesthesia Tray · Burron Medical Products, Inc. · 19840
  1. Root · 2 generations backK840287 Brachial Plexus Anesthesia TrayBurron Medical Products, Inc. · 1984
  2. 1 generation backK022019 Perifix Catheter ConnectorB.Braun Medical, Inc. · 2002
  3. This deviceK032144 Perifix Catheter ConnectorB.Braun Medical, Inc. · 2003
  4. Descendant · cites it directly · 0 of its ownK051171 Stingray Epidural Catheter ConnectorEpimed International, Inc. · 2005 · Recalled

Most influential descendants

Showing 1 of 1 · See all
  • K051171Stingray Epidural Catheter ConnectorEpimed International, Inc. · 2005 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K840287Brachial Plexus Anesthesia TrayBurron Medical Products, Inc.1984—
−1K022019Perifix Catheter ConnectorB.Braun Medical, Inc.2002—
0 (this device)K032144Perifix Catheter ConnectorB.Braun Medical, Inc.2003—
+1K051171Stingray Epidural Catheter ConnectorEpimed International, Inc.20051

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
FIG. 1 — Lineage of K032144, 1984–2005Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K261372 Profoject™ LOR Syringescore 12.4 · 2 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against? (1)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K022019Perifix Catheter Connector
Summary page 1
…rifix Catheter Connector will be available in two different configurations. The first configuration is the one cleared in 5 10(k) K022019. This new configuration is the same as the previously cleared device except it has a slightly larger inner di…
B.Braun Medical, Inc.2002—

Also cleared against K022019: 2 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K051171Stingray Epidural Catheter ConnectorEpimed International, Inc.20050

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jul 20, 2018Class IIZ-3331-2018Under Investigation by firmThe catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.
Jul 20, 2018Class IIZ-3332-2018Under Investigation by firmThe catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 19 years and passes through 2 companies; a new generation was cleared every 18.4 years on median.
  • None of the 2 ancestors has a recall.
  • Of its descendants, K051171 (Epimed International, Inc., 2005) has gone furthest, with 0 descendants of its own.
  • 2 other devices also cite its predicate K022019.

How does its category compare?

All CAZ devices

CAZ Anesthesia Conduction Kit: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CAZ

1in 2023

2007: 42008: 42009: 22010: 22011: 12012: 92015: 12016: 22019: 12020: 12021: 12022: 12023: 12026 (partial year): 1
2007high 9 (2012) · low 0 (2013)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CAZ

108in 2012

2007: 172 days median2008: 99 days median2012: 108 days median
2007high 172 (2007) · low 99 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · CAZ

1in 2024

2009: 292010: 82011: 22013: 122014: 22015: 12016: 12024: 12026 (partial year): 12, 11 Class I
2007high 29 (2009) · low 0 (2007)2026

Class I (11 since 2007) Class II/III not classified

Adverse event reports per year · CAZ

137in 2025

2007: 812008: 802009: 1342010: 1392011: 1872012: 1872013: 2762014: 2512015: 2352016: 3722017: 3532018: 4482019: 4722020: 2742021: 1652022: 2702023: 602024: 1652025: 137
2007high 472 (2019) · low 60 (2023)2025

MAUDE reports naming product code CAZ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20074172081
2008499080
20092—29134
20102—8139
20111—2187
201291080187
20130—12276
20140—2251
20151—1235
20162—1372
20170—0353
20180—0448
20191—0472
20201—0274
20211—0165
20221—0270
20231—060
20240—1165
20250—0137
20261—12 (11)—

What is it indicated for?

A connection device used to provide various anesthetic and fluid administration devices with a single, common access point to 18 - 19 gauge Perifix catheter for delivery of anesthetics, The connector is used in conjunction with 18 - 19 gauge. Perifix catheters for continuous administration of anesthetic agents.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K032144: Perifix Catheter Connector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K032144

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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