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

Medela AG · Predicate Candidate Screening

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

149 daysmedian FDA review time

292 days90th percentile

30clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K251377	Magic InBra	Medela AG	2025-09-18	139	0
K223388	Invia® Integrated Dressing	Medela AG	2023-07-07	242	0
K214112	Invia Ease Negative Pressure Wound Therapy (NPWT) System	Medela AG	2022-07-26	208	0
K191653	Freestyle Flex	Medela AG	2019-10-17	119	0
K182191	Invia Abdominal Dressing Kit	Medela AG	2019-02-01	172	0
K180415	Invia White Foam NPWT	Medela AG	2018-11-02	260	0
K172145	Invia Foam Dressing Kits With FitPad, Invia Motion Negative	Medela AG	2018-05-09	296	0
K170088	Invia Foam Dressing Kits with FitPad, Invia Foam Dressing Ki	Medela AG	2017-04-06	86	0
K161128	Invia Motion-Endure Negative Pressure Wound Therapy System,	Medela AG	2016-12-01	224	1
K153663	Vario 8/18/ci	Medela AG	2016-05-18	149	0
K151632	Symphony Breastpump, Symphony reconditioned, Symphony Preemi	Medela AG	2015-11-05	141	0
K151261	Invia Foam Dressing Kit Small, Invia Foam Dressing Kit Mediu	Medela AG	2015-10-07	148	0
K142626	Invia Liberty Negative Pressure Wound Therapy System, Invia	Medela AG	2015-06-12	269	0
K150134	Basic, Dominant Flex, KV-6	Medela AG	2015-04-21	90	0
K150499	Freestyle Deluxe, Freestyle Solution Set, Freestyle Basic, F	Medela AG	2015-04-21	54	0
K141926	INVIA ENDURE NEGATIVE PRESSURE WOUND THERAPY SYSTEM	Medela AG	2014-12-19	156	0
K141553	MEDELA THOPAZ+	Medela AG	2014-08-25	75	0
K130123	BASIC AND DOMINANT FLEX SUCTION PUMPS	Medela AG	2013-10-11	267	0
K130210	MEDELA THOPAZ	Medela AG	2013-03-15	45	0
K113678	INVIA MOTION NEGATIVE PRESSURE WOUND THERAPY SYSTEM	Medela AG	2012-10-01	292	0
K080357	MEDELA INVIA WOUND THERAPY	Medela AG	2008-07-24	164	1
K080212	MEDELA THOPAZ, MODEL 200 0288	Medela AG	2008-07-23	176	0
K063336	MEDELA DOMINANT 50 LIPO, MODEL 600-5706	Medela AG	2007-02-26	112	0
K061205	MEDELA VARIO 8/18/CI SECRETION & SURGICAL ASPIRATOR	Medela AG	2006-06-21	51	1
K061435	MEDELA VARIO SUCTION PUMPS	Medela AG	2006-06-08	15	0
K053052	MEDELA SWING BREAST PUMP	Medela AG	2006-05-02	183	0
K041579	MEDELA SINGLE USE SILC CUP, MODEL 077.0791	Medela AG	2005-04-21	311	0
K043544	MEDELA DOMINANT 35 C/I SECRETION AND SURGICAL ASPIRATOR	Medela AG	2005-01-07	15	0
K033179	MEDELA CLARIO HOME CARE PUMP	Medela AG	2003-10-15	14	0
K021368	MEDELA BASIC 30 AND DOMINANT 50 SUCTION PUMPS, MODELS 037, 0	Medela AG	2002-05-15	15	0

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