Atlas FDA

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

Medela, LLC · Predicate Candidate Screening

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

141 daysmedian FDA review time
228 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K253510Freestyle Mini Hands-freeMedela, LLC2026-04-101560
K253149Motion InBra (YM-8801) wearable breast pumpMedela, LLC2026-02-131410
K253498Pump In Style® Pro+Medela, LLC2026-01-22850
K232608Duo Hands-free Breast PumpMedela, LLC2024-04-122280
K210759Solo, Swing MaxiMedela, LLC2021-08-111490
K200508Pump In StyleMedela, LLC2020-06-151050
K181937Pump In Style Advanced, Advanced Personal Double BreastpumpMedela, LLC2018-10-16890

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