Atlas FDA

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

Stockert GmbH — Predicate Candidate Screening

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

129 daysmedian FDA review time
162 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K070336STOCKERT NEURO N50, MODEL12267Stockert GmbH2007-06-141290
K070134MODIFICATION TO STIMUPLEX HNS-12, MODEL 4892098Stockert GmbH2007-03-22650
K061983STIMUPLEX PENStockert GmbH2006-11-211310
K052313STIMUPLEX HNS-12, MODEL 4892098Stockert GmbH2005-11-17840
K003983STIMUPLEX HNS-11Stockert GmbH2001-06-061620

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