Medela AG
Medical device manufacturer in Mchenry, IL.
56510(k) clearances
0PMA approvals
13recalls
Device types
- HGX Pump, Breast, Powered 19
- OMP Negative Pressure Wound Therapy Powered… 13
- BTA Pump, Portable, Aspiration (Manual Or… 10
- HGY Pump, Breast, Non-Powered 3
- HDB Extractor, Vacuum, Fetal 3
- HFS Shield, Nipple 2
- LBI Unit, Neonatal Phototherapy 2
- QPB System, Suction, Lipoplasty For Removal 2
- LHB Timer, Apgar 1
- PNR Enteral Syringes With Enteral Specific… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K253510 | Freestyle Mini Hands-freeHGX · Traditional | 04/10/2026SE |
| K253149 | Motion InBra (YM-8801) wearable breast pumpHGX · Traditional | 02/13/2026SE |
| K253498 | Pump In Style® Pro+HGX · Special | 01/22/2026SE |
| K251377 | Magic InBraHGX · Traditional | 09/18/2025SE |
| K232608 | Duo Hands-free Breast PumpHGX · Special | 04/12/2024SE |
| K223388 | Invia® Integrated DressingOMP · Traditional | 07/07/2023SE |
| K214112 | Invia Ease Negative Pressure Wound Therapy (NPWT) SystemOMP · Traditional | 07/26/2022SE |
| K210759 | Solo, Swing MaxiHGX · Traditional | 08/11/2021SE |
| K200508 | Pump In StyleHGX · Traditional | 06/15/2020SE |
| K191653 | Freestyle FlexHGX · Traditional | 10/17/2019SE |
| K182191 | Invia Abdominal Dressing KitOMP · Traditional | 02/01/2019SE |
| K180415 | Invia White Foam NPWTOMP · Traditional | 11/02/2018SE |
| K181937 | Pump In Style Advanced, Advanced Personal Double BreastpumpHGX · Traditional | 10/16/2018SE |
| K172145 | Invia Foam Dressing Kits With FitPad, Invia Motion Negative Pressure Wound Therapy…OMP · Traditional | 05/09/2018SE |
| K170088 | Invia Foam Dressing Kits with FitPad, Invia Foam Dressing Kits with FitPad, Invia Gauze…OMP · Traditional | 04/06/2017SE |
| K161811 | Medela Low Dose Enteral SyringePNR · Traditional | 02/15/2017SE |
| K161128 | Invia Motion-Endure Negative Pressure Wound Therapy System, Invia Motion-7-120 Days…OMP · Traditional | 12/01/2016SE |
| K161725 | Sonata Breastpump Deluxe, Sonata Warranty Breastpump, Double pumping Tubing Kit, retail…HGX · Traditional | 10/28/2016SE |
| K153663 | Vario 8/18/ciBTA · Traditional | 05/18/2016SE |
| K151632 | Symphony Breastpump, Symphony reconditioned, Symphony Preemie+ Breastpump, Symphony Plus…HGX · Traditional | 11/05/2015SE |
| K151261 | Invia Foam Dressing Kit Small, Invia Foam Dressing Kit Medium, Invia Foam Dressing Kit…OMP · Traditional | 10/07/2015SE |
| K142626 | Invia Liberty Negative Pressure Wound Therapy System, Invia Liberty Tubing Set…OMP · Traditional | 06/12/2015SE |
| K150499 | Freestyle Deluxe, Freestyle Solution Set, Freestyle Basic, Freestyle Motor WarrantyHGX · Traditional | 04/21/2015SE |
| K150134 | Basic, Dominant Flex, KV-6QPB · Traditional | 04/21/2015SE |
| K141926 | Invia Endure Negative Pressure Wound Therapy SystemOMP · Traditional | 12/19/2014SE |
| K141553 | Medela Thopaz+BTA · Special | 08/25/2014SE |
| K130123 | Basic and Dominant Flex Suction PumpsBTA · Traditional | 10/11/2013SE |
| K130210 | Medela ThopazBTA · Traditional | 03/15/2013SE |
| K113678 | Invia Motion Negative Pressure Wound Therapy SystemOMP · Traditional | 10/01/2012SE |
| K080357 | Medela Invia Wound TherapyOMP · Traditional | 07/24/2008SE |
| K080212 | Medela Thopaz, Model 200 0288BTA · Traditional | 07/23/2008SE |
| K063336 | Medela Dominant 50 Lipo, Model 600-5706QPB · Traditional | 02/26/2007SE |
| K061205 | Medela Vario 8/18/CI Secretion & Surgical AspiratorBTA · Traditional | 06/21/2006SE |
| K061435 | Medela Vario Suction PumpsOMP · Traditional | 06/08/2006SE |
| K053052 | Medela Swing Breast PumpHGX · Traditional | 05/02/2006SE |
| K041579 | Medela Single Use Silc Cup, Model 077.0791HDB · Traditional | 04/21/2005SE |
| K043544 | Medela Dominant 35 C/I Secretion and Surgical AspiratorBTA · Traditional | 01/07/2005SE |
| K033179 | Medela Clario Home Care PumpBTA · Abbreviated | 10/15/2003SE |
| K031614 | Medela Pump in Style Advanced Breast PumpHGX · Traditional | 06/06/2003SE |
| K021368 | Medela Basic 30 and Dominant 50 Suction Pumps, Models 037, 057BTA · Traditional | 05/15/2002SE |
| K020518 | Medela Symphony Breast Pump, Model 024HGX · Traditional | 03/07/2002SE |
| K984589 | Phototherapy LampLBI · Traditional | 04/20/1999SE |
| K983552 | Basic, Median, Dominant, and VarioBTA · Abbreviated | 01/07/1999SE |
| K962612 | Bilibed Phototherapy LampLBI · Traditional | 12/12/1996SE |
| K950750 | Medelas Breast PumpHGX · Traditional | 10/16/1995SE |
| K952034 | Medela's Foot PumpHGY · Traditional | 09/12/1995SE |
| K923577 | Breast ShellsHFS · Traditional | 01/22/1993SE |
| K901344 | Medela Battery Operated Breast PumpHGX · Traditional | 08/06/1990SE |
| K875300 | Medela Breast-Pump LactinaHGX · Traditional | 04/06/1988SE |
| K853176 | Cannon Babysafe Nipple ShieldsHFS · Traditional | 08/22/1985SE |
| K844297 | Supplemental Feeding SystemHGY · Traditional | 02/25/1985SE |
| K841492 | AB Vacuum Extractor Silc-CupHDB · Traditional | 05/07/1984SE |
| K834129 | Medela Apgar TimerLHB · Traditional | 01/10/1984SE |
| K830012 | Medela Suction PumpHDB · Traditional | 01/24/1983SE |
| K823840 | Medela Namual Breast PumpHGY · Traditional | 01/24/1983SE |
| K801862 | Medela Electric Breast PumpHGX · Traditional | 10/23/1980SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-2645-2026 Class II | Brand Name: Medela Product Name: ENFit ExSet Strl 60 2.0ml PV 1ct EN Model/Catalog…May contain incorrect connectors and will not attach or misconnect to ENFit connections and is thus… | 06/05/2026Open, Classified |
| Z-0773-2020 Class II | Invia Foam Dressing Kit with FitPad - X-Large (3 pcs) SKU # 0876224. The Invia Foam…Invia Foam Dressing Kit with FitPad could have holes in the sterile packaging. | 12/02/2019Terminated |
| Z-2061-2019 Class III | Breast Milk Transfer Lid for use with Oral Syringe Connectors Model: 90003S-100The sterility may be compromised due to a potential breach in the packaging, even though it may appear intact. | 12/05/2018Terminated |
| Z-2528-2018 Class II | Invia Motion Negative Pressure Wound Therapy System. Labeled as: a. Endure Negative…Device may display a battery missing error. | 02/07/2018Terminated |
| Z-3172-2011 | Wound Dressing Kit - Tier I, 10 MM Flat Drain; product code 0877061. Medela Healthcare…Medela determined that some of the individual kits or bags of lot #370118 of "0877061 Wound Dressing Set… | 07/27/2011Terminated |
| Z-2553-2011 | Contact Nipple Shield (Sterile) - 24mm (Standard); Individually wrapped silicone contact…The product sterility may be compromised due to possible pinholes in the rigid tray of the package. | 05/18/2011Terminated |
| Z-2386-2011 | AC Power Adaptor (transformer), TENPAO Model U090100Q31; used with the Pump In Style…The power adaptor (transformer) used with the Pump In Style Advanced family of breast pumps have power cords… | 04/04/2011Terminated |
| Z-1224-2011 | Pump in Style Advanced (PNSA)Breast Pump; a daily use, double pump, electric powered…The performance of the pumps may be compromised due to the potentiometer used on the circuit board. Affected… | 01/10/2011Terminated |
| Z-2486-2010 | Sterile single/double breast personal accessory convenience kit for the Lactina Breast…The product sterility may be compromised due to possible pinholes in the rigid tray of the package. | 08/06/2010Terminated |
| Z-2485-2010 | Sterile single/double breast personal accessory convenience kit for single or double…The product sterility may be compromised due to possible pinholes in the rigid tray of the package. | 08/06/2010Terminated |
| Z-2484-2010 | Sterile double breast personal accessory convenience kit for the Symphony or Lactina…The product sterility may be compromised due to possible pinholes in the rigid tray of the package. | 08/06/2010Terminated |
| Z-2483-2010 | Sterile double breast personal accessory convenience kit for the Symphony Breast pump…The product sterility may be compromised due to possible pinholes in the rigid tray of the package. | 08/06/2010Terminated |
| Z-1442-2010 | Instruction for Use for Symphony Double Pumping Kit; Medela, Inc., P.O. Box 660, 1101…The non-sterile devices were erroneously packaged with instructions stating the devices are sterile and do… | 03/15/2010Terminated |