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

Medela, Inc. — Predicate Candidate Screening

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

99 daysmedian FDA review time
229 days90th percentile
19clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K161811Medela Low Dose Enteral SyringeMedela, Inc.2017-02-152290
K161725Sonata Breastpump Deluxe, Sonata Warranty Breastpump, DoubleMedela, Inc.2016-10-281280
K031614MEDELA PUMP IN STYLE ADVANCED BREAST PUMPMedela, Inc.2003-06-06141
K020518MEDELA SYMPHONY BREAST PUMP, MODEL 024Medela, Inc.2002-03-07163
K984589PHOTOTHERAPY LAMPMedela, Inc.1999-04-201170
K983552BASIC, MEDIAN, DOMINANT, AND VARIOMedela, Inc.1999-01-07900
K962612BILIBED PHOTOTHERAPY LAMPMedela, Inc.1996-12-121620
K950750MEDELAS BREAST PUMPMedela, Inc.1995-10-162411
K952034MEDELA'S FOOT PUMPMedela, Inc.1995-09-121340
K923577BREAST SHELLSMedela, Inc.1993-01-221860
K901344MEDELA BATTERY OPERATED BREAST PUMPMedela, Inc.1990-08-061370
K875300MEDELA BREAST-PUMP LACTINAMedela, Inc.1988-04-06993
K853176CANNON BABYSAFE NIPPLE SHIELDSMedela, Inc.1985-08-22410
K844297SUPPLEMENTAL FEEDING SYSTEMMedela, Inc.1985-02-251190
K841492AB VACUUM EXTRACTOR SILC-CUPMedela, Inc.1984-05-07270
K834129MEDELA APGAR TIMERMedela, Inc.1984-01-10410
K830012MEDELA SUCTION PUMPMedela, Inc.1983-01-24210
K823840MEDELA NAMUAL BREAST PUMPMedela, Inc.1983-01-24341
K801862MEDELA ELECTRIC BREAST PUMPMedela, Inc.1980-10-23791

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