# PAJUNK GmbH Medizintechnologie

- Location (FDA's records): Geisingen, DE
- FDA decisions: 44 (2006–2025): 44 510(k) clearances
- Product codes: BSP (13), CAZ (8), BSO (3), HAW (3), GCJ (3), KNW (2), GEI (2), BXN (2), DYB (1), BSN (1), FCG (1), FMJ (1)
- 510(k) review time since 2016: median 210 days, against 170 for FDA's reviews in the same codes and years (7 of 15 faster)
- Predicates its devices cite: 73 (14 its own); citations of its devices by later devices: 26 (14 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Pajunk GmbH: 29 (https://510kreport.com/company/pajunk)
- B.Braun Medical, Inc.: 3 (https://510kreport.com/company/b-braun-medical)
- Manan Medical Products, Inc.: 2 (https://510kreport.com/company/manan-medical-products)
- Radionics, A Division of Tyco Healthcare Group LP: 2 (https://510kreport.com/company/radionics-a-division-of-tyco-healthcare-group)
- I-Flow Corp.: 2 (https://510kreport.com/company/i-flow)
- Macosta Medical USA, LLC: 1 (https://510kreport.com/company/macosta-medical-usa)
- Portex, Inc.: 1 (https://510kreport.com/company/portex)
- Medevice, Inc.: 1 (https://510kreport.com/company/medevice)

## Firms that cite its devices most
- Ad-Tech Medical Instrument Corp: 1 (https://510kreport.com/company/ad-tech-medical-instrument)
- Becton, Dickinson & CO: 1 (https://510kreport.com/company/becton-dickinson)
- Genicon, Inc.: 1 (https://510kreport.com/company/genicon)
- Pajunk GmbH: 1 (https://510kreport.com/company/pajunk)
- International Medical Development, Inc.(Imd): 1 (https://510kreport.com/company/international-medical-development-imd)
- Surgical Structures, Ltd.: 1 (https://510kreport.com/company/surgical-structures)
- Rudolf Medical GmbH + Co. KG: 1 (https://510kreport.com/company/rudolf-medical)
- Jiangsu Caina Medical Co.,Ltd: 1 (https://510kreport.com/company/jiangsu-caina-medical)

## Its most-cited devices
- K160294: SPROTTE NRFit, Quincke NRFit Lumbar Puncture needles (2016), cited by 3
- K060311: Epilong Kit for Anesthesiology (2006), cited by 3
- K062900: Pajunks Stimulong Tsui-Method Set (2007), cited by 2
- K062047: Adaptable Monopolar Adaptable and/or Retractable Electrodes (2006), cited by 2
- K060808: Brainpro, Brainpro Access (2006), cited by 2
- K090631: Pajunk Disposable Balloons and Balloon Systems (2009), cited by 2

## Recent decisions
- K243690: SonoMSK (Jul 1, 2025)
- K243682: SonoPlex STIM; SonoPlex II (Jun 27, 2025)
- K250774: SPROTTE® STANDARD (LUER/ NRFit®) Lumbar Puncture (Jun 25, 2025)
- K243525: SonoTAP and SonoTAP II (Mar 24, 2025)
- K241953: SPROTTE® STANDARD (LUER/ NRFit®) Anesthesiology (Nov 22, 2024)
- K241954: SonoBlock; SonoBlock II (Sep 11, 2024)
- K230701: Stim2Go (Nov 24, 2023)
- K230201: Disposable Pre-calibrated Brain Biopsy Needle 2.0 (Feb 22, 2023)

Source page: https://510kreport.com/company/pajunk-medizintechnologie