510(k) Report

FDA applicant

Pajunk GmbH

Geisingen, DE19 decisions1991–20125 recalls

FDA records 19 decisions for Pajunk GmbH (Geisingen, DE) from 1991 to 2012: 19 510(k) clearances. Most are in product codes BSP (Needle, Conduction, Anesthetic (W/Wo Introducer)) and CAZ (Anesthesia Conduction Kit). Its devices cite 42 predicates, 31 of them its own earlier devices. 5 recalls are linked to its devices, 1 Class I.

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

FIG. A — Illustration, anesthesiology panel, where it files most

How often FDA has decided Pajunk GmbH’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2011: 12012: 1
2007high 1 (2011) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2026

2019: 42026 (partial year): 1, 1 Class I
2007high 4 (2019) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Pajunk GmbH by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • BSPNeedle, Conduction, Anesthetic (W/Wo Introducer)8decisions
  • CAZAnesthesia Conduction Kit5decisions
  • GCJLaparoscope, General & Plastic Surgery3decisions
  • KNWInstrument, Biopsy1decision
  • GEIElectrosurgical, Cutting & Coagulation & Accessories1decision
  • BXNStimulator, Nerve, Battery-Powered1decision

Whose devices does it build on?

Its devices cite 42 predicates; 31 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 85 times; 31 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K040965Pajunk Tuohy Needles, Quincke Needles, Chiba Needles & Crawford NeedlesPajunk GmbH · 200411cite it
  • K013041Plexolong SetsPajunk GmbH · 200210cite it
  • K000722Unipolar NeedlesPajunk GmbH · 20009cite it
  • K033018Stimulong Plus Catheter Set Model, VariousPajunk GmbH · 20048cite it
  • K113207Sono Tap, Tuohy SonoPajunk GmbH · 20127cite it
  • K023218Modification to Plexolong SetsPajunk GmbH · 20036cite it

What has FDA decided for it lately?

  • K113207Sono Tap, Tuohy SonoPajunk GmbH · 2012
  • K113209Chiba SonoPajunk GmbH · 2011
  • K060563Epispin, Epispin II Safety, Epispin II, Epispin I, Epispin IVPajunk GmbH · 2006
  • K053283Uniplex Nanoline Cannula, Plexolong Nanoline Set, Stimulong Nanoline SetPajunk GmbH · 2006
  • K053282Adaptable Monopolar Electrodes with Ceramic TipPajunk GmbH · 2005
  • K043130Modification to Pajunk Stimulong Plus Catheter SetsPajunk GmbH · 2004
  • K042979Modification to: Plexalong SetsPajunk GmbH · 2004
  • K040965Pajunk Tuohy Needles, Quincke Needles, Chiba Needles & Crawford NeedlesPajunk GmbH · 2004

All 19 as Pajunk GmbH →

What has been recalled?

5 recalls linked to its devices; the latest:

  • K911202Description/REF: SPINAL ANESTHESIA KIT/ASA-24090-SB; SPINAL ANESTHESIA KIT/ASA-24103-SB…Apr 21, 2026Class I
  • K911260Arrow SPINAL ANESTHESIA SET ASA-25090-SDec 20, 2019Class II
  • K911260Sprotte Needle, REF 32115130C w/ Intro 22 G x 3.5", distributed by Teleflex Medical The…Oct 11, 2019Class II
  • K911260Sprotte Needle, REF 33115131B w/ Intro 20 G x 3.5", distributed by Teleflex Medical The…Oct 11, 2019Class II
  • K911260SPROTTE Lumbar with Introducer, labeled as the following: 1. Sprotte 22G x 90mm w/…Aug 30, 2019Class II

Other applicant names beginning “Pajunk”

FDA records each applicant name separately; these may or may not be the same firm.

PAJUNK GmbH Medizintechnologie 44