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Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Pajunk GmbH — Predicate Candidate Screening

19 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

121 daysmedian FDA review time
412 days90th percentile
19clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K113207SONO TAP, TUOHY SONOPajunk GmbH2012-02-291210
K113209CHIBA SONOPajunk GmbH2011-11-21210
K060563EPISPIN, EPISPIN II SAFETY, EPISPIN II, EPISPIN I, EPISPIN IPajunk GmbH2006-06-021140
K053283UNIPLEX NANOLINE CANNULA, PLEXOLONG NANOLINE SET, STIMULONG Pajunk GmbH2006-01-12480
K053282ADAPTABLE MONOPOLAR ELECTRODES WITH CERAMIC TIPPajunk GmbH2005-12-13180
K042979MODIFICATION TO: PLEXALONG SETSPajunk GmbH2004-12-21530
K043130MODIFICATION TO PAJUNK STIMULONG PLUS CATHETER SETSPajunk GmbH2004-12-21390
K040965PAJUNK TUOHY NEEDLES, QUINCKE NEEDLES, CHIBA NEEDLES & CRAWFPajunk GmbH2004-09-071460
K033018STIMULONG PLUS CATHETER SET MODEL, VARIOUSPajunk GmbH2004-05-052220
K033249PAJUNK MODULAR HANDLE INSTRUMENTSPajunk GmbH2004-03-051500
K023218MODIFICATION TO PLEXOLONG SETSPajunk GmbH2003-03-241790
K013041PLEXOLONG SETSPajunk GmbH2002-06-112740
K011308MULTISTIMPajunk GmbH2001-11-292130
K012771TROCAR SLEEVE AND ACCESSORIES, MODELS 1287-XX-XXPajunk GmbH2001-11-14890
K011997MODULAR VALVE HANDLES FOR ADAPTABLE TUBES, MODEL 1298-XX-XX,Pajunk GmbH2001-07-10130
K000722UNIPOLAR NEEDLESPajunk GmbH2000-03-31280
K911221ATRAUMATIC SPECIAL SPROTTE NEEDLEPajunk GmbH1992-07-244930
K911202ATRAUMATIC STANDARD SPROTTE NEEDLEPajunk GmbH1992-05-044121
K911260ATRAUMATIC STANDARD SPROTTE NEEDLEPajunk GmbH1991-10-212131

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