510(k) Report

510(k) · Cleared

Recalled · Class II · 2024

Stingray Epidural Catheter Connector

K051171510(k) TraditionalCleared Aug 26, 2005112-day reviewClass II21 CFR 868.5140Recalls 1

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

Epimed International, Inc. · CAZ Anesthesia Conduction Kit

Cleared on Aug 26, 2005 as substantially equivalent to K032144 (B.Braun Medical, Inc., 2003) after a 112-day review. Its family tree reaches back 3 generations to 1984. It has been recalled once.

Decided
Aug 26, 2005
Review
112 days
Class
Class II
Product code
CAZ
Recalls
1
Predicates
1

Its longest line of descent runs back 3 generations to K840287 (1984). No later device cites it as a predicate yet.

  1. Root · 3 generations backK840287 Brachial Plexus Anesthesia TrayBurron Medical Products, Inc. · 1984
  2. 2 generations backK022019 Perifix Catheter ConnectorB.Braun Medical, Inc. · 2002
  3. 1 generation backK032144 Perifix Catheter ConnectorB.Braun Medical, Inc. · 2003 · Recalled
  4. This deviceK051171 Stingray Epidural Catheter ConnectorEpimed International, Inc. · 2005
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K840287Brachial Plexus Anesthesia TrayBurron Medical Products, Inc.1984—
−2K022019Perifix Catheter ConnectorB.Braun Medical, Inc.2002—
−1K032144Perifix Catheter ConnectorB.Braun Medical, Inc.20032
0 (this device)K051171Stingray Epidural Catheter ConnectorEpimed International, Inc.2005—
FIG. 1 — Lineage of K051171, 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
*K032144Perifix Catheter Connector
Summary page 1
…onduction Catheter Kit Product Class/Classificationi: Class H1 - CAZ, 21 CFR 868.5140 Predicate Device(s): B. Braun Medical Perifixe Catheter Connector 0(032144) Description: The Stingray Epidural Catheter Connector consists of two molded plastic body Sections that are that…
B.Braun Medical, Inc.20032

What descends from it?

No later submission names this one as a predicate yet.

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

Recalls of this device

DateClassRecallRoot causeReason
Oct 16, 2024Class IIZ-0508-2025Under Investigation by firmThe connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 21 years and passes through 3 companies; a new generation was cleared every 1.9 years on median.
  • 1 of the 3 ancestors has a recall of any class.

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?

The Stingray Epidural Catheter Connector is intended to provide various anesthetic and fluid administration devices with a single, common access point to an epidural catheter for delivery of anesthetics. The connector is used in conjunction with an epidural catheter for continuous administration of anesthetic agents.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K051171: Stingray Epidural 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/K051171

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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