Atlas FDA

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

Somnomedics GmbH · Predicate Candidate Screening

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

222 daysmedian FDA review time
324 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K240700HomeSleepTest (HST, HST REM+)Somnomedics GmbH2024-12-082690
K231104ABPMproSomnomedics GmbH2023-11-272220
K212325EEG-acpSomnomedics GmbH2022-06-153240
K201054SOMNOscreen plusSomnomedics GmbH2020-08-121130
K140861SOMNOTOUCH RESPSomnomedics GmbH2015-01-303020
K081485SOMNOWATCHSomnomedics GmbH2008-09-181130
K071556SOMNOSCREEN EEG10-20Somnomedics GmbH2007-07-18410

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