Atlas FDA

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

Stihler Electronic GmbH — Predicate Candidate Screening

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

148 daysmedian FDA review time
194 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K260278ThermAffyx(TM) Patient Safety SystemStihler Electronic GmbH2026-07-081600
K202197Astopad Patient Warming SystemStihler Electronic GmbH2020-09-04300
K082758PRISMAFLO IIStihler Electronic GmbH2008-12-19910
K082765ASTOFLO PLUSStihler Electronic GmbH2008-12-18870
K020103PRISMAFLOStihler Electronic GmbH2002-07-241940
K991159PRISMATHERM II, ASTOLINEStihler Electronic GmbH1999-09-031490
K991160ASTOTHERM PLUS, ASTOTUBES, ASTOLINEStihler Electronic GmbH1999-09-021480

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