Atlas FDA

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

Zephyr Sleep Technologies — Predicate Candidate Screening

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

129 daysmedian FDA review time
245 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K200695MATRx plusZephyr Sleep Technologies2020-08-241600
K191925MATRx PlusZephyr Sleep Technologies2019-10-291030
K181996MATRx PlusZephyr Sleep Technologies2018-11-211180
DEN170090MATRx plusZephyr Sleep Technologies2018-08-232450
K163665MATRx plusZephyr Sleep Technologies2017-05-051290

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