510(k) Report

FDA applicant

PAJUNK GmbH Medizintechnologie

Geisingen, DE44 decisions2006–20250 recalls

FDA records 44 decisions for PAJUNK GmbH Medizintechnologie (Geisingen, DE) from 2006 to 2025: 44 510(k) clearances. Most are in product codes BSP (Needle, Conduction, Anesthetic (W/Wo Introducer)) and CAZ (Anesthesia Conduction Kit). Since 2016 its 510(k)s took a median of 210 days from receipt to decision, against 170 for FDA’s reviews in the same codes and years. Its devices cite 73 predicates, 14 of them its own earlier devices. No recall is linked to its devices.

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 Medizintechnologie’s devices, and how often a recall has named them.

FDA decisions per year

4in 2025

2007: 62008: 62009: 12011: 12012: 22016: 52017: 32018: 12019: 22020: 12022: 12023: 22024: 22025: 4
2007high 6 (2007) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “PAJUNK”

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