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

Leonhard Lang GmbH — Predicate Candidate Screening

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

52 daysmedian FDA review time
132 days90th percentile
17clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K142803Skintact, various other tradenamesLeonhard Lang GmbH2014-12-02642
K140500SKINTACTLeonhard Lang GmbH2014-07-291520
K140340SKINTACTLeonhard Lang GmbH2014-05-21990
K103186SKINTACT RADIOTRANSPARENT MULTIFUNCTION ELECTRODESLeonhard Lang GmbH2011-02-081020
K092291SKINTACT AND VARIOUS OTHER TRADENAMESLeonhard Lang GmbH2009-08-21230
K081371SKINTACT PEDIATRIC MULTIFUNCTION ELECTRODES WITH DH03 GELLeonhard Lang GmbH2008-09-241321
K080106SKINTACT PRE-WIRED ECG ELECTRODES WITH CONDUCTIVE ADHESIVELeonhard Lang GmbH2008-02-01170
K073104SKINTACT AND VARIOUS OTHER TRADENAMESLeonhard Lang GmbH2007-11-16140
K072233SKINTACT MULTIFUNCTIONAL ELECTRODES WITH DH02 GEL WITH DIFFELeonhard Lang GmbH2007-10-05562
K063161SKINTACT COOL CONTACT ELECTROSURGICAL GROUNDING PLATE WITH NLeonhard Lang GmbH2006-11-21350
K041883SKINTACT MULTIFUNCTION ELECTRODES, MODEL DF 21Leonhard Lang GmbH2004-09-07570
K040249SKINTACT ECG ELECTRODELeonhard Lang GmbH2004-02-24210
K030362SKINTACT COOL CONTACT ELECTROSURGICAL GROUNDING PLATESLeonhard Lang GmbH2003-04-14700
K030509SKINTACT ECG TAB ELECTRODELeonhard Lang GmbH2003-03-04130
K023920SKINTACTLeonhard Lang GmbH2003-01-16520
K024247SKINTACT ECG ELECTRODES WITH KL 02 LIQUID GELLeonhard Lang GmbH2003-01-16242
K023503SKINTACT ECG ELECTRODELeonhard Lang GmbH2002-11-14270

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