510(k) Report

510(k) · Cleared

Cleared

Stimulong Plus Catheter Set Model, Various

K033018510(k) TraditionalCleared May 5, 2004222-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

Pajunk GmbH · CAZ Anesthesia Conduction Kit

Cleared on May 5, 2004 as substantially equivalent to K000722 (Pajunk GmbH, 2000) and 3 other predicates after a 222-day review. Its family tree reaches back 3 generations to 1984. 1 of the 33 devices in its family, counting itself, has a Class I recall. 23 later devices descend from it.

Decided
May 5, 2004
Review
222 days
Class
Class II
Product code
CAZ
Recalls
None
Predicates
4

Its longest line of descent runs back 3 generations to K840287 (1984). 9 ancestors in all, the oldest K801912 (1980). 23 later devices descend from it, 8 citing it directly. 1 of the 33 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2003: 1 other ancestor2000: 2 other ancestors2002: 1 other ancestor1983: 1 other ancestor1980: 1 other ancestor, 1 with a Class I recall12007: 2 descendants cleared2004: 1 descendant cleared2006: 2 descendants cleared2008: 2 descendants cleared2020: 3 descendants cleared2012: 3 descendants cleared2018: 2 descendants cleared2009: 1 descendant cleared2010: 1 descendant cleared2023: 1 descendant cleared2014: 1 descendant cleared2016: 1 descendant cleared2015: 1 descendant cleared2022: 1 descendant cleared2024: 1 descendant clearedK840287 · Brachial Plexus Anesthesia Tray · Burron Medical Products, Inc. · 1984K013041 · Plexolong Sets · Pajunk GmbH · 2002K023218 · Modification to Plexolong Sets · Pajunk GmbH · 200319801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 2 other ancestors3 generations back: 2 other ancestors, 1 with a Class I recall1 1 generation forward: 8 descendants2 generations forward: 3 descendants3 generations forward: 2 descendants4 generations forward: 5 descendants5 generations forward: 4 descendants6 generations forward: 1 descendant K023218 · Modification to Plexolong Sets · Pajunk GmbH · 2003K013041 · Plexolong Sets · Pajunk GmbH · 2002K840287 · Brachial Plexus Anesthesia Tray · Burron Medical Products, Inc. · 19840+5
  1. Root · 3 generations backK840287 Brachial Plexus Anesthesia TrayBurron Medical Products, Inc. · 1984
  2. 2 generations backK013041 Plexolong SetsPajunk GmbH · 2002
  3. 1 generation backK023218 Modification to Plexolong SetsPajunk GmbH · 2003
  4. This deviceK033018 Stimulong Plus Catheter Set Model, VariousPajunk GmbH · 2004
  5. Descendant · cites it directly · 13 of its ownK063282 Contiplex Stim Continuous Nerve Block SetB.Braun Medical, Inc. · 2007
  6. Descendant · 2 generations on · 12 of its ownK090995 B. Braun Contiplex Continuous Nerve Block SetB.Braun Medical, Inc. · 2009
  7. Descendant · 3 generations on · 7 of its ownK100241 Contiplex D Continuous Nerve Block Set, Model 331687, 331686…B.Braun Medical, Inc. · 2010
  8. Descendant · cites it directly · 4 of its ownK043130 Modification to Pajunk Stimulong Plus Catheter SetsPajunk GmbH · 2004
  9. Descendant · 3 generations on · 3 of its ownK113059 Contiplex FXB.Braun Medical, Inc. · 2012

Showing 5 of 23 descendants. See all descendants

Descendants cleared per year

2004: 12006: 22007: 22008: 22009: 12010: 12012: 32014: 12015: 12016: 12018: 22020: 32022: 12023: 12024: 1
2004high 3 (2012) · low 0 (2005)2026

Class I recalls in this family

Most influential descendants

Showing 5 of 23 · See all
  • K063282Contiplex Stim Continuous Nerve Block SetB.Braun Medical, Inc. · 2007 · cites it directly13descendants
  • K090995B. Braun Contiplex Continuous Nerve Block SetB.Braun Medical, Inc. · 2009 · 2 generations on12descendants
  • K100241Contiplex D Continuous Nerve Block Set, Model 331687, 331686, 331685, 331680B.Braun Medical, Inc. · 2010 · 3 generations on7descendants
  • K043130Modification to Pajunk Stimulong Plus Catheter SetsPajunk GmbH · 2004 · cites it directly4descendants
  • K113059Contiplex FXB.Braun Medical, Inc. · 2012 · 3 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K840287Brachial Plexus Anesthesia TrayBurron Medical Products, Inc.1984—
−2K013041Plexolong SetsPajunk GmbH2002—
−1K023218Modification to Plexolong SetsPajunk GmbH2003—
0 (this device)K033018Stimulong Plus Catheter Set Model, VariousPajunk GmbH2004—
+1K063282Contiplex Stim Continuous Nerve Block SetB.Braun Medical, Inc.2007—
+2K090995B. Braun Contiplex Continuous Nerve Block SetB.Braun Medical, Inc.2009—
+3K100241Contiplex D Continuous Nerve Block Set, Model 331687, 331686, 331685, 331680B.Braun Medical, Inc.2010—
+1K043130Modification to Pajunk Stimulong Plus Catheter SetsPajunk GmbH2004—
+3K113059Contiplex FXB.Braun Medical, Inc.2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198011
198310
200020
200210
200310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200620
200720
200820
200910
201010
201230
201410
201510
201610
201820
202030
202210
202310
202410
FIG. 1 — Lineage of K033018, 1984–2024Source: 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 summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

1 device in this family has 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? (4)

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
*K000722Unipolar Needles
Summary page 1
…r and catheter adapter. All Pajunk conduction cannula with nerve stimulus connector and tubing have been cleared for market by the FDA under 51 0(k) number K000722 (Unipolar facet and Sprotte tip). The Plexolong anesthesia sets which include a catheter and catheter adapter were…
Pajunk GmbH2000—
*K013041Plexolong Sets
Summary page 1
…(Unipolar facet and Sprotte tip). The Plexolong anesthesia sets which include a catheter and catheter adapter were cleared for market under FDA 51 0(k) No. K01 3041 and the Tuohy tip cannula with stimulus connector and tubing, catheter and catheter adapter have been cleared for m…
Pajunk GmbH2002—
*K023218Modification to Plexolong Sets
Summary page 1
…3041 and the Tuohy tip cannula with stimulus connector and tubing, catheter and catheter adapter have been cleared for market by the FDA under 51 0(k) No. K023218, (Plexolong Tuohy tip conduction anesthesia sets). The indications for use for all Plexolong sets is identical to t…
Pajunk GmbH2003—
*K030937Stimucath Continuous Nerve Block Set, Models AB-02030, AB-02060, AB-02090, AB-02030-PK…
Summary page 2
…ductive tip, wire and alternate plastic material is located in Section 7 of this submission. Use of a conduction catheter was cleared by FDA under 510(k) No. K030937. The Stimulong Plus Catheter Sets are supplied in polypropylene containers that are sealed to assure sterility. 5…
Arrow International, Inc.20031

Also cleared against K000722: 8 other devices →

What descends from it? (23)

See all 23

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

NumberDeviceApplicantDecidedDescendants
K063282Contiplex Stim Continuous Nerve Block SetB.Braun Medical, Inc.200713
K043130Modification to Pajunk Stimulong Plus Catheter SetsPajunk GmbH20044
K062900Pajunks Stimulong Tsui-Method SetPAJUNK GmbH Medizintechnologie20072
K053283Uniplex Nanoline Cannula, Plexolong Nanoline Set, Stimulong Nanoline SetPajunk GmbH20062
K060563Epispin, Epispin II Safety, Epispin II, Epispin I, Epispin IVPajunk GmbH20061
K202699E-Cath STIM acc. TsuiPAJUNK GmbH Medizintechnologie20200
K113188Sonolong Sono, Curl Sono, Nanoline, Brand Names Carryingsono/SonolongPAJUNK GmbH Medizintechnologie20120
K082164Pajunk's Generic Convenience Tray for Regional Anesthesia of the Peripheral Plexus…PAJUNK GmbH Medizintechnologie20080

Has anything in its family been recalled? (1 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.

  • K801912Arrow Positive Placement Con/Epidural anArrow Intl., Inc. · 1980 · 3 generations back · ◆ in the 1980 ancestors bar of FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 20 years and passes through 2 companies; a new generation was cleared every 1.1 years on median.
  • 3 of the 9 ancestors have a recall of any class; 1 has a Class I recall.
  • Of its descendants, K063282 (B.Braun Medical, Inc., 2007) has gone furthest, with 13 descendants of its own.
  • 8 other devices also cite its predicate K000722.

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 Pajunk Stimulong Plus Catheter Sets are intended for delivery of continuous conduction anesthesia of peripheral nerves and plexus for up to 72 hours. Continuous delivery is accomplished using the conduction catheter. To assist the physician pinpoint the area of application an electrical stimulus can be applied to the conduction needle and after placement of the conduction catheter to its tip via the catheter adapter.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K033018: Stimulong Plus Catheter Set Model, Various.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033018

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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