Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
PAJUNK GmbH Medizintechnologie · Predicate Candidate Screening
44 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
123 daysmedian FDA review time
267 days90th percentile
44clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K243690 | SonoMSK | PAJUNK GmbH Medizintechnologie | 2025-07-01 | 214 | 0 |
| K243682 | SonoPlex STIM; SonoPlex II | PAJUNK GmbH Medizintechnologie | 2025-06-27 | 210 | 0 |
| K250774 | SPROTTE® STANDARD (LUER/ NRFit®) Lumbar Puncture | PAJUNK GmbH Medizintechnologie | 2025-06-25 | 103 | 0 |
| K243525 | SonoTAP and SonoTAP II | PAJUNK GmbH Medizintechnologie | 2025-03-24 | 130 | 0 |
| K241953 | SPROTTE® STANDARD (LUER/ NRFit®) Anesthesiology | PAJUNK GmbH Medizintechnologie | 2024-11-22 | 142 | 0 |
| K241954 | SonoBlock; SonoBlock II | PAJUNK GmbH Medizintechnologie | 2024-09-11 | 70 | 0 |
| K230701 | Stim2Go | PAJUNK GmbH Medizintechnologie | 2023-11-24 | 255 | 0 |
| K230201 | Disposable Pre-calibrated Brain Biopsy Needle 2.0 | PAJUNK GmbH Medizintechnologie | 2023-02-22 | 28 | 0 |
| K220897 | Disposable Brain Biopsy Needle 2.0 | PAJUNK GmbH Medizintechnologie | 2022-08-17 | 142 | 0 |
| K202699 | E-Cath STIM acc. Tsui | PAJUNK GmbH Medizintechnologie | 2020-12-29 | 104 | 0 |
| K190663 | Epidural MiniFilter LUER 80369-7, Epidural MiniFilter NRFit | PAJUNK GmbH Medizintechnologie | 2019-06-17 | 94 | 0 |
| K190345 | VPC | PAJUNK GmbH Medizintechnologie | 2019-05-16 | 91 | 0 |
| K172777 | Catheter Clamping Adapter LUER 80369-7, Catheter Clamping Ad | PAJUNK GmbH Medizintechnologie | 2018-05-03 | 231 | 0 |
| K170305 | Spinal Manometer NRFit; Spinal Manometer LUER | PAJUNK GmbH Medizintechnologie | 2017-07-25 | 175 | 0 |
| K170435 | NerveGuard NRFit, NerveGuard LUER | PAJUNK GmbH Medizintechnologie | 2017-07-12 | 149 | 0 |
| K162086 | MultiStim ECO | PAJUNK GmbH Medizintechnologie | 2017-01-06 | 163 | 0 |
| K160297 | Tuohy NRFit | PAJUNK GmbH Medizintechnologie | 2016-10-28 | 268 | 0 |
| K160295 | SPROTTE NRFit, Quincke NRFit | PAJUNK GmbH Medizintechnologie | 2016-10-27 | 267 | 0 |
| K160296 | SPROTTE SPECIAL NRFit | PAJUNK GmbH Medizintechnologie | 2016-10-27 | 267 | 0 |
| K160294 | SPROTTE NRFit, Quincke NRFit Lumbar Puncture needles | PAJUNK GmbH Medizintechnologie | 2016-10-21 | 261 | 0 |
| K152952 | E-Cath | PAJUNK GmbH Medizintechnologie | 2016-07-13 | 281 | 0 |
| K113188 | SONOLONG SONO, CURL SONO, NANOLINE, BRAND NAMES CARRYINGSONO | PAJUNK GmbH Medizintechnologie | 2012-03-01 | 122 | 0 |
| K113196 | VASCULAR SONO | PAJUNK GmbH Medizintechnologie | 2012-02-06 | 98 | 0 |
| K111374 | SONO-SERIES CORNERSTONE TECHNIQUE | PAJUNK GmbH Medizintechnologie | 2011-08-29 | 105 | 0 |
| K090631 | PAJUNK DISPOSABLE BALLOONS AND BALLOON SYSTEMS | PAJUNK GmbH Medizintechnologie | 2009-04-16 | 38 | 0 |
| K082183 | PAJUNK'S GENERIC CONVENIENCE TRAY FOR REGIONAL ANESTHESIA: C | PAJUNK GmbH Medizintechnologie | 2008-10-28 | 88 | 0 |
| K082164 | PAJUNK'S GENERIC CONVENIENCE TRAY FOR REGIONAL ANESTHESIA OF | PAJUNK GmbH Medizintechnologie | 2008-10-27 | 88 | 0 |
| K080675 | PAJUNK INFILTRALONG WOUND INFILTRATION CATHETER KIT | PAJUNK GmbH Medizintechnologie | 2008-06-20 | 102 | 0 |
| K080674 | PAJUNK'S PRIMOCUT DISPOSABLE BIOPSY SYSTEM | PAJUNK GmbH Medizintechnologie | 2008-05-09 | 60 | 0 |
| K080654 | PAJUNK'S KIT FOR BALLOON AIDED LAPAROSCOPY | PAJUNK GmbH Medizintechnologie | 2008-05-08 | 62 | 0 |
| K063350 | DUAL-CANNULA SYSTEM ACC. MANCAO, SPECIAL SPROTTE | PAJUNK GmbH Medizintechnologie | 2008-02-01 | 452 | 0 |
| K062902 | PAJUNKS EPILONG SET PEDIATRIC | PAJUNK GmbH Medizintechnologie | 2007-06-07 | 253 | 0 |
| K063233 | DELTACUT (APPARATUS AND CANNULA) | PAJUNK GmbH Medizintechnologie | 2007-04-30 | 187 | 0 |
| K070179 | TROKABONE, TROKABONE STERNAL | PAJUNK GmbH Medizintechnologie | 2007-03-07 | 47 | 0 |
| K063697 | SPECIAL SPROTTE, CHIBA, DR STEINHOFF KIT | PAJUNK GmbH Medizintechnologie | 2007-02-14 | 63 | 0 |
| K063528 | TROCASYS | PAJUNK GmbH Medizintechnologie | 2007-01-17 | 56 | 0 |
| K062900 | PAJUNKS STIMULONG TSUI-METHOD SET | PAJUNK GmbH Medizintechnologie | 2007-01-12 | 107 | 0 |
| K061172 | PAJUNK MULTISTIM SENSOR NERVE STIMULATORS | PAJUNK GmbH Medizintechnologie | 2006-10-17 | 173 | 0 |
| K062097 | VERESS CANNULA AND MODULAR VERESS CANNULA | PAJUNK GmbH Medizintechnologie | 2006-10-13 | 81 | 0 |
| K062047 | ADAPTABLE MONOPOLAR ADAPTABLE AND/OR RETRACTABLE ELECTRODES | PAJUNK GmbH Medizintechnologie | 2006-10-05 | 77 | 0 |
| K062072 | PAJUNKS DISPOSABLE INSERTS FOR HANDLE INSTRUMENTS AND HF ELE | PAJUNK GmbH Medizintechnologie | 2006-09-22 | 63 | 0 |
| K060397 | RF LESION CANNULA, RF THERMOLESION CANNULA, THERMOLESION CAN | PAJUNK GmbH Medizintechnologie | 2006-08-31 | 197 | 0 |
| K060808 | BRAINPRO, BRAINPRO ACCESS | PAJUNK GmbH Medizintechnologie | 2006-07-25 | 123 | 0 |
| K060311 | EPILONG KIT FOR ANESTHESIOLOGY | PAJUNK GmbH Medizintechnologie | 2006-06-13 | 125 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda