Atlas FDA

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

Erich Jaeger GmbH — Predicate Candidate Screening

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

110 daysmedian FDA review time
419 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K023120OXYCON MOBILEErich Jaeger GmbH2003-11-124190
K023796MS PAED-BABY BODYErich Jaeger GmbH2003-03-031100
K021138SLEEPSCREEN/APNOESCREEN CARDIOErich Jaeger GmbH2003-02-123090
K001502AEROSOL PROVOCATION SYSTEM APS PRO, MODEL APS PROErich Jaeger GmbH2000-07-12580
K000648SPIRO PROErich Jaeger GmbH2000-03-29300

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