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

Resmed Germany, Inc. · Predicate Candidate Screening

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

134 daysmedian FDA review time
285 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K143272ApneaLink AirResmed Germany, Inc.2015-04-301670
K131932APNEALINK PROResmed Germany, Inc.2013-11-081340
K122715STELLAR 150Resmed Germany, Inc.2013-06-172850
K113640STELLAR 150Resmed Germany, Inc.2012-04-051180
K103167STELLAR 150Resmed Germany, Inc.2011-03-011250
K083575APNEALINK PLUS, MODEL: 22328Resmed Germany, Inc.2009-03-191060
K070263APNEALINKResmed Germany, Inc.2007-06-151400
K061405APNEALINK, MODEL 22302Resmed Germany, Inc.2006-07-25670

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