510(k) Report

510(k) · Cleared

Cleared

Cla Kit (Continuous Local Anesthesia), Model 551-17, 551-10, 551-07

K994059510(k) TraditionalCleared Oct 13, 2000319-day reviewClass II21 CFR 868.5140

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

Hdc Corp. · CAZ Anesthesia Conduction Kit

Cleared on Oct 13, 2000 after a 319-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 of the 32 devices in its family, counting itself, have a Class I recall. 31 later devices descend from it.

Decided
Oct 13, 2000
Review
319 days
Class
Class II
Product code
CAZ
Recalls
None
Predicates
0

31 later devices descend from it, 3 citing it directly. 2 of the 32 devices in this family, counting this one, have a Class I recall.

Descendants, by year cleared 2003: 2 descendants cleared2006: 2 descendants cleared2012: 5 descendants cleared, 2 with a Class I recall22007: 2 descendants cleared2004: 2 descendants cleared2017: 1 descendant cleared2008: 2 descendants cleared2018: 2 descendants cleared2020: 3 descendants cleared2009: 1 descendant cleared2010: 1 descendant cleared2016: 2 descendants cleared2014: 2 descendants cleared2023: 1 descendant cleared2015: 1 descendant cleared2022: 1 descendant cleared2024: 1 descendant cleared200020052010201520202025
  1. This deviceK994059 Cla Kit (Continuous Local Anesthesia), Model 551-17, 551-10, 551-07Hdc Corp. · 2000
  2. Descendant · cites it directly · 29 of its ownK030937 Stimucath Continuous Nerve Block Set, Models AB-02030, AB-02060…Arrow International, Inc. · 2003 · Recalled
  3. Descendant · 2 generations on · 23 of its ownK033018 Stimulong Plus Catheter Set Model, VariousPajunk GmbH · 2004
  4. Descendant · 2 generations on · 13 of its ownK063282 Contiplex Stim Continuous Nerve Block SetB.Braun Medical, Inc. · 2007
  5. Descendant · 3 generations on · 12 of its ownK090995 B. Braun Contiplex Continuous Nerve Block SetB.Braun Medical, Inc. · 2009
  6. Descendant · 4 generations on · 7 of its ownK100241 Contiplex D Continuous Nerve Block Set, Model 331687, 331686…B.Braun Medical, Inc. · 2010

Showing 5 of 31 descendants. See all descendants

Descendants cleared per year

2003: 22004: 22006: 22007: 22008: 22009: 12010: 12012: 52014: 22015: 12016: 22017: 12018: 22020: 32022: 12023: 12024: 1
2003high 5 (2012) · low 0 (2005)2026

Class I recalls in this family

Most influential descendants

Showing 5 of 31 · See all
  • K030937Stimucath Continuous Nerve Block Set, Models AB-02030, AB-02060, AB-02090, AB-02030-PK…Arrow International, Inc. · 2003 · cites it directly29descendants
  • K033018Stimulong Plus Catheter Set Model, VariousPajunk GmbH · 2004 · 2 generations on23descendants
  • K063282Contiplex Stim Continuous Nerve Block SetB.Braun Medical, Inc. · 2007 · 2 generations on13descendants
  • K090995B. Braun Contiplex Continuous Nerve Block SetB.Braun Medical, Inc. · 2009 · 3 generations on12descendants
  • K100241Contiplex D Continuous Nerve Block Set, Model 331687, 331686, 331685, 331680B.Braun Medical, Inc. · 2010 · 4 generations on7descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K994059Cla Kit (Continuous Local Anesthesia), Model 551-17, 551-10, 551-07Hdc Corp.2000—
+1K030937Stimucath Continuous Nerve Block Set, Models AB-02030, AB-02060, AB-02090…Arrow International, Inc.20031
+2K033018Stimulong Plus Catheter Set Model, VariousPajunk GmbH2004—
+2K063282Contiplex Stim Continuous Nerve Block SetB.Braun Medical, Inc.2007—
+3K090995B. Braun Contiplex Continuous Nerve Block SetB.Braun Medical, Inc.2009—
+4K100241Contiplex D Continuous Nerve Block Set, Model 331687, 331686, 331685, 331680B.Braun Medical, Inc.2010—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200320
200420
200620
200720
200820
200910
201010
201252
201420
201510
201620
201710
201820
202030
202210
202310
202410
FIG. 1 — Lineage of K994059, 2000–2024Source: 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 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

2 devices in this family have a Class I recall. 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
Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (31)

See all 31

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K030937Stimucath Continuous Nerve Block Set, Models AB-02030, AB-02060, AB-02090, AB-02030-PK…Arrow International, Inc.200329
K053283Uniplex Nanoline Cannula, Plexolong Nanoline Set, Stimulong Nanoline SetPajunk GmbH20062
K022752Pandin Continuous Nerve Stimulating Catheter, Models 561-18-05, 561-18-09, 561-18-15…Hdc Corp.20030

Has anything in its family been recalled? (2 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K121403Continuous Peripheral Nerve Block Catheter Kit and SetTeleflex, Inc. · 2012 · 2 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
  • K122027Arrow Flexblock Continuous Peripheral Nerve Block CatheterArrow International, Inc. · 2012 · 3 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Of its descendants, K030937 (Arrow International, Inc., 2003) has gone furthest, with 29 descendants of its own.

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 CLA Kit (Nerve Block Infusion Kit) is intended for the injection of local anesthetic to achieve peripheral nerve conduction blocks, by use of an insulated hollow needle for electrical stimulation to locate peripheral nerves, and the injection of local anesthetic either directly through the needle, or for up to 72 hours via a catheter inserted through the needle.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

Cite this page

510(k) Report. “K994059: Cla Kit (Continuous Local Anesthesia), Model 551-17, 551-10, 551-07.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K994059

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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