# Medela AG

- Location (FDA's records): Mchenry, IL
- FDA decisions: 56 (1980–2026): 56 510(k) clearances
- Names in FDA's records: Medela AG (30); Medela, Inc. (19); Medela, LLC (7)
- Product codes: HGX (19), OMP (13), BTA (10), HGY (3), HDB (3), QPB (2), HFS (2), LBI (2), LHB (1), PNR (1)
- 510(k) review time since 2016: median 149 days, against 149 for FDA's reviews in the same codes and years (11 of 19 faster)
- Predicates its devices cite: 70 (45 its own); citations of its devices by later devices: 116 (45 its own)
- Recalls linked to its devices: 12 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Hollister, Inc.: 2 (https://510kreport.com/company/hollister)
- Kci USA, Inc.: 2 (https://510kreport.com/company/kci-usa)
- Genadyne Biotechnologies, Inc.: 1 (https://510kreport.com/company/genadyne-biotechnologies)
- Hk Surgical, Inc.: 1 (https://510kreport.com/company/hk-surgical)
- Moeller Medical GmbH & Co. KG: 1 (https://510kreport.com/company/moeller-medical)
- Kinetic Concepts, Inc.: 1 (https://510kreport.com/company/kinetic-concepts)
- Lansinoh Laboratories Saglik Gerecleri Tasarim San: 1 (https://510kreport.com/company/lansinoh-laboratories-saglik-gerecleri-tasarim-san)
- Jedmed Instrument Co.: 1 (https://510kreport.com/company/jedmed-instrument)

## Firms that cite its devices most
- Genadyne Biotechnologies, Inc.: 3 (https://510kreport.com/company/genadyne-biotechnologies)
- Ardo Medical AG: 3 (https://510kreport.com/company/ardo-medical)
- Evenflo Company, Inc.: 3 (https://510kreport.com/company/evenflo)
- Hygeia Medical, Inc.: 2 (https://510kreport.com/company/hygeia-medical)
- Dao Health: 2 (https://510kreport.com/company/dao-health)
- Simex Medizintechnik GmbH: 2 (https://510kreport.com/company/simex-medizintechnik)
- Playtex Products, Inc.: 2 (https://510kreport.com/company/playtex-products)
- Avent America, Inc.: 2 (https://510kreport.com/company/avent-america)

## Its most-cited devices
- K983552: Basic, Median, Dominant, and Vario (1999), cited by 9
- K950750: Medelas Breast Pump (1995), cited by 9
- K021368: Medela Basic 30 and Dominant 50 Suction Pumps, Models 037, 057 (2002), cited by 8
- K080357: Medela Invia Wound Therapy (2008), cited by 7
- K031614: Medela Pump in Style Advanced Breast Pump (2003), cited by 7
- K150499: Freestyle Deluxe, Freestyle Solution Set, Freestyle Basic, Freestyle Motor Warranty (2015), cited by 6

## Recent decisions
- K253510: Freestyle Mini Hands-free (Apr 10, 2026)
- K253149: Motion InBra (YM-8801) wearable breast pump (Feb 13, 2026)
- K253498: Pump In Style® Pro+ (Jan 22, 2026)
- K251377: Magic InBra (Sep 18, 2025)
- K232608: Duo Hands-free Breast Pump (Apr 12, 2024)
- K223388: Invia® Integrated Dressing (Jul 7, 2023)
- K214112: Invia Ease Negative Pressure Wound Therapy (NPWT) System (Jul 26, 2022)
- K210759: Solo, Swing Maxi (Aug 11, 2021)

Source page: https://510kreport.com/company/medela