Atlas FDA

Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Wieland Edelmetalle GmbH & Co. · Predicate Candidate Screening

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

70 daysmedian FDA review time
89 days90th percentile
14clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K020347AGC SPEZIALLEGIERUNGWieland Edelmetalle GmbH & Co.2002-04-24790
K012839AUROPAL, ORDER-NO.: 2101Wieland Edelmetalle GmbH & Co.2001-12-311300
K012841DUO PAL 6, ORDER-NO.: 2154Wieland Edelmetalle GmbH & Co.2001-11-20890
K012843PORTADUR P 2, MODEL #2031Wieland Edelmetalle GmbH & Co.2001-11-02710
K012826BIOPORTA G, MODEL 2052Wieland Edelmetalle GmbH & Co.2001-11-01700
K012827PORTA AURIUM, MODEL 2067Wieland Edelmetalle GmbH & Co.2001-11-01700
K012828PORTA SMK 82, MODEL 2032Wieland Edelmetalle GmbH & Co.2001-11-01700
K012831BIO PORTADUR, ORDER-NO.:2017Wieland Edelmetalle GmbH & Co.2001-11-01700
K012834PORTA GEO TI MODEL #2004Wieland Edelmetalle GmbH & Co.2001-11-01700
K012835PORTA MAXIMUM, MODEL# 2066Wieland Edelmetalle GmbH & Co.2001-11-01700
K012838ERO50, ORDER-NO.: 2070Wieland Edelmetalle GmbH & Co.2001-10-23610
K012840EURO 45, ORDER-NO.: 2064Wieland Edelmetalle GmbH & Co.2001-10-23610
K012156IMAGINE H.E.Wieland Edelmetalle GmbH & Co.2001-08-16360
K001041AGC-GOLD ELECTROLYTE FOR AGC-MICRO, AGC-GOLD ELECTROLYTE FORWieland Edelmetalle GmbH & Co.2000-05-23530

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