Atlas FDA

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-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K243690SonoMSKPAJUNK GmbH Medizintechnologie2025-07-012140
K243682SonoPlex STIM; SonoPlex IIPAJUNK GmbH Medizintechnologie2025-06-272100
K250774SPROTTE® STANDARD (LUER/ NRFit®) Lumbar PuncturePAJUNK GmbH Medizintechnologie2025-06-251030
K243525SonoTAP and SonoTAP IIPAJUNK GmbH Medizintechnologie2025-03-241300
K241953SPROTTE® STANDARD (LUER/ NRFit®) AnesthesiologyPAJUNK GmbH Medizintechnologie2024-11-221420
K241954SonoBlock; SonoBlock IIPAJUNK GmbH Medizintechnologie2024-09-11700
K230701Stim2GoPAJUNK GmbH Medizintechnologie2023-11-242550
K230201Disposable Pre-calibrated Brain Biopsy Needle 2.0PAJUNK GmbH Medizintechnologie2023-02-22280
K220897Disposable Brain Biopsy Needle 2.0PAJUNK GmbH Medizintechnologie2022-08-171420
K202699E-Cath STIM acc. TsuiPAJUNK GmbH Medizintechnologie2020-12-291040
K190663Epidural MiniFilter LUER 80369-7, Epidural MiniFilter NRFit PAJUNK GmbH Medizintechnologie2019-06-17940
K190345VPCPAJUNK GmbH Medizintechnologie2019-05-16910
K172777Catheter Clamping Adapter LUER 80369-7, Catheter Clamping AdPAJUNK GmbH Medizintechnologie2018-05-032310
K170305Spinal Manometer NRFit; Spinal Manometer LUERPAJUNK GmbH Medizintechnologie2017-07-251750
K170435NerveGuard NRFit, NerveGuard LUERPAJUNK GmbH Medizintechnologie2017-07-121490
K162086MultiStim ECOPAJUNK GmbH Medizintechnologie2017-01-061630
K160297Tuohy NRFitPAJUNK GmbH Medizintechnologie2016-10-282680
K160295SPROTTE NRFit, Quincke NRFitPAJUNK GmbH Medizintechnologie2016-10-272670
K160296SPROTTE SPECIAL NRFitPAJUNK GmbH Medizintechnologie2016-10-272670
K160294SPROTTE NRFit, Quincke NRFit Lumbar Puncture needlesPAJUNK GmbH Medizintechnologie2016-10-212610
K152952E-CathPAJUNK GmbH Medizintechnologie2016-07-132810
K113188SONOLONG SONO, CURL SONO, NANOLINE, BRAND NAMES CARRYINGSONOPAJUNK GmbH Medizintechnologie2012-03-011220
K113196VASCULAR SONOPAJUNK GmbH Medizintechnologie2012-02-06980
K111374SONO-SERIES CORNERSTONE TECHNIQUEPAJUNK GmbH Medizintechnologie2011-08-291050
K090631PAJUNK DISPOSABLE BALLOONS AND BALLOON SYSTEMSPAJUNK GmbH Medizintechnologie2009-04-16380
K082183PAJUNK'S GENERIC CONVENIENCE TRAY FOR REGIONAL ANESTHESIA: CPAJUNK GmbH Medizintechnologie2008-10-28880
K082164PAJUNK'S GENERIC CONVENIENCE TRAY FOR REGIONAL ANESTHESIA OFPAJUNK GmbH Medizintechnologie2008-10-27880
K080675PAJUNK INFILTRALONG WOUND INFILTRATION CATHETER KITPAJUNK GmbH Medizintechnologie2008-06-201020
K080674PAJUNK'S PRIMOCUT DISPOSABLE BIOPSY SYSTEMPAJUNK GmbH Medizintechnologie2008-05-09600
K080654PAJUNK'S KIT FOR BALLOON AIDED LAPAROSCOPYPAJUNK GmbH Medizintechnologie2008-05-08620
K063350DUAL-CANNULA SYSTEM ACC. MANCAO, SPECIAL SPROTTEPAJUNK GmbH Medizintechnologie2008-02-014520
K062902PAJUNKS EPILONG SET PEDIATRICPAJUNK GmbH Medizintechnologie2007-06-072530
K063233DELTACUT (APPARATUS AND CANNULA)PAJUNK GmbH Medizintechnologie2007-04-301870
K070179TROKABONE, TROKABONE STERNALPAJUNK GmbH Medizintechnologie2007-03-07470
K063697SPECIAL SPROTTE, CHIBA, DR STEINHOFF KITPAJUNK GmbH Medizintechnologie2007-02-14630
K063528TROCASYSPAJUNK GmbH Medizintechnologie2007-01-17560
K062900PAJUNKS STIMULONG TSUI-METHOD SETPAJUNK GmbH Medizintechnologie2007-01-121070
K061172PAJUNK MULTISTIM SENSOR NERVE STIMULATORSPAJUNK GmbH Medizintechnologie2006-10-171730
K062097VERESS CANNULA AND MODULAR VERESS CANNULAPAJUNK GmbH Medizintechnologie2006-10-13810
K062047ADAPTABLE MONOPOLAR ADAPTABLE AND/OR RETRACTABLE ELECTRODESPAJUNK GmbH Medizintechnologie2006-10-05770
K062072PAJUNKS DISPOSABLE INSERTS FOR HANDLE INSTRUMENTS AND HF ELEPAJUNK GmbH Medizintechnologie2006-09-22630
K060397RF LESION CANNULA, RF THERMOLESION CANNULA, THERMOLESION CANPAJUNK GmbH Medizintechnologie2006-08-311970
K060808BRAINPRO, BRAINPRO ACCESSPAJUNK GmbH Medizintechnologie2006-07-251230
K060311EPILONG KIT FOR ANESTHESIOLOGYPAJUNK GmbH Medizintechnologie2006-06-131250

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