Company · US
Medela AG
FDA 510(k) clearances and medical device recalls filed under this name, 1980 to 2026. Name variants (Inc, Corp, punctuation) are merged.
56510(k) clearances (3 in 12 months)
13recalls (1 in 12 months)
12recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| HGX | Pump, Breast, Powered | 25 |
| OMP | Negative Pressure Wound Therapy Powered Suction Pump | 15 |
| BTA | Pump, Portable, Aspiration (Manual Or Powered) | 10 |
| HDB | Extractor, Vacuum, Fetal | 3 |
| HFS | Shield, Nipple | 3 |
| HGY | Pump, Breast, Non-Powered | 3 |
| LBI | Unit, Neonatal Phototherapy | 2 |
| QPB | System, Suction, Lipoplasty For Removal | 2 |
| FMF | Syringe, Piston | 1 |
| FPA | Set, Administration, Intravascular | 1 |
| LHB | Timer, Apgar | 1 |
| MCY | Wound Dressing Kit | 1 |
| OHH | Breast Pump Kit | 1 |
| PNR | Enteral Syringes With Enteral Specific Connectors | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 10, 2026 | K253510 | Freestyle Mini Hands-free Medela, LLC | HGX |
| Feb 13, 2026 | K253149 | Motion InBra (YM-8801) wearable breast pump Medela, LLC | HGX |
| Jan 22, 2026 | K253498 | Pump In Style® Pro+ Medela, LLC | HGX |
| Sep 18, 2025 | K251377 | Magic InBra Medela AG, CH | HGX |
| Apr 12, 2024 | K232608 | Duo Hands-free Breast Pump Medela, LLC | HGX |
| Jul 7, 2023 | K223388 | Invia® Integrated Dressing Medela AG, CH | OMP |
| Jul 26, 2022 | K214112 | Invia Ease Negative Pressure Wound Therapy (NPWT) System Medela AG, CH | OMP |
| Aug 11, 2021 | K210759 | Solo, Swing Maxi Medela, LLC | HGX |
| Jun 15, 2020 | K200508 | Pump In Style Medela, LLC | HGX |
| Oct 17, 2019 | K191653 | Freestyle Flex Medela AG, CH | HGX |
| Feb 1, 2019 | K182191 | Invia Abdominal Dressing Kit Medela AG, CH | OMP |
| Nov 2, 2018 | K180415 | Invia White Foam NPWT Medela AG, CH | OMP |
| Oct 16, 2018 | K181937 | Pump In Style Advanced, Advanced Personal Double Breastpump Medela, LLC | HGX |
| May 9, 2018 | K172145 | Invia Foam Dressing Kits With FitPad, Invia Motion Negative Pressure Wound Therapy System (Invia Motion - Endure, Invia Medela AG, CH | OMP |
| Apr 6, 2017 | K170088 | Invia Foam Dressing Kits with FitPad, Invia Foam Dressing Kits with FitPad, Invia Gauze Dressing Kits with FitPad, Invia Medela AG, CH | OMP |
| Feb 15, 2017 | K161811 | Medela Low Dose Enteral Syringe Medela, Inc. | PNR |
| Dec 1, 2016 | K161128 | Invia Motion-Endure Negative Pressure Wound Therapy System, Invia Motion-7-120 Days Negative Pressure Wound Therapy Syst Medela AG, CH | OMP |
| Oct 28, 2016 | K161725 | Sonata Breastpump Deluxe, Sonata Warranty Breastpump, Double pumping Tubing Kit, retail, Connector spare parts kit, Sili Medela, Inc. | HGX |
| May 18, 2016 | K153663 | Vario 8/18/ci Medela AG, CH | BTA |
| Nov 5, 2015 | K151632 | Symphony Breastpump, Symphony reconditioned, Symphony Preemie+ Breastpump, Symphony Plus Breastpump (battery version), S Medela AG, CH | HGX |
| Oct 7, 2015 | K151261 | Invia Foam Dressing Kit Small, Invia Foam Dressing Kit Medium, Invia Foam Dressing Kit Large Medela AG, CH | OMP |
| Jun 12, 2015 | K142626 | Invia Liberty Negative Pressure Wound Therapy System, Invia Liberty Tubing Set, Y-connector, Drain Adaptor, Invia Libert Medela AG, CH | OMP |
| Apr 21, 2015 | K150499 | Freestyle Deluxe, Freestyle Solution Set, Freestyle Basic, Freestyle Motor Warranty Medela AG, CH | HGX |
| Apr 21, 2015 | K150134 | Basic, Dominant Flex, KV-6 Medela AG, CH | QPB |
| Dec 19, 2014 | K141926 | INVIA ENDURE NEGATIVE PRESSURE WOUND THERAPY SYSTEM Medela AG | OMP |
| Aug 25, 2014 | K141553 | MEDELA THOPAZ+ Medela AG, CH | BTA |
| Oct 11, 2013 | K130123 | BASIC AND DOMINANT FLEX SUCTION PUMPS Medela AG | BTA |
| Mar 15, 2013 | K130210 | MEDELA THOPAZ Medela AG, CH | BTA |
| Oct 1, 2012 | K113678 | INVIA MOTION NEGATIVE PRESSURE WOUND THERAPY SYSTEM Medela AG | OMP |
| Jul 24, 2008 | K080357 | MEDELA INVIA WOUND THERAPY Medela AG, CH | OMP |
| Jul 23, 2008 | K080212 | MEDELA THOPAZ, MODEL 200 0288 Medela AG, CH | BTA |
| Feb 26, 2007 | K063336 | MEDELA DOMINANT 50 LIPO, MODEL 600-5706 Medela AG, CH | QPB |
| Jun 21, 2006 | K061205 | MEDELA VARIO 8/18/CI SECRETION & SURGICAL ASPIRATOR Medela AG, CH | BTA |
| Jun 8, 2006 | K061435 | MEDELA VARIO SUCTION PUMPS Medela AG, CH | OMP |
| May 2, 2006 | K053052 | MEDELA SWING BREAST PUMP Medela AG, CH | HGX |
| Apr 21, 2005 | K041579 | MEDELA SINGLE USE SILC CUP, MODEL 077.0791 Medela AG, CH | HDB |
| Jan 7, 2005 | K043544 | MEDELA DOMINANT 35 C/I SECRETION AND SURGICAL ASPIRATOR Medela AG, CH | BTA |
| Oct 15, 2003 | K033179 | MEDELA CLARIO HOME CARE PUMP Medela AG, CH | BTA |
| Jun 6, 2003 | K031614 | MEDELA PUMP IN STYLE ADVANCED BREAST PUMP Medela, Inc. | HGX |
| May 15, 2002 | K021368 | MEDELA BASIC 30 AND DOMINANT 50 SUCTION PUMPS, MODELS 037, 057 Medela AG, CH | BTA |
| Mar 7, 2002 | K020518 | MEDELA SYMPHONY BREAST PUMP, MODEL 024 Medela, Inc., CH | HGX |
| Apr 20, 1999 | K984589 | PHOTOTHERAPY LAMP Medela, Inc. | LBI |
| Jan 7, 1999 | K983552 | BASIC, MEDIAN, DOMINANT, AND VARIO Medela, Inc. | BTA |
| Dec 12, 1996 | K962612 | BILIBED PHOTOTHERAPY LAMP Medela, Inc. | LBI |
| Oct 16, 1995 | K950750 | MEDELAS BREAST PUMP Medela, Inc. | HGX |
| Sep 12, 1995 | K952034 | MEDELA'S FOOT PUMP Medela, Inc. | HGY |
| Jan 22, 1993 | K923577 | BREAST SHELLS Medela, Inc. | HFS |
| Aug 6, 1990 | K901344 | MEDELA BATTERY OPERATED BREAST PUMP Medela, Inc. | HGX |
| Apr 6, 1988 | K875300 | MEDELA BREAST-PUMP LACTINA Medela, Inc. | HGX |
| Aug 22, 1985 | K853176 | CANNON BABYSAFE NIPPLE SHIELDS Medela, Inc. | HFS |
Newest 50 of 56.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 1, 2026 | Medela Inc Brand Name: Medela
Product Name: ENFit ExSet Strl 60 2.0ml PV 1ct EN
Model/Catalog Number: ENF060182LD / 101033086
Software Version: N/A
Product Description: Enteral Extension Set, Length 60 Orange- Open, Classified |
FPA | K895367 |
| Dec 2, 2019 | Medela Inc Invia Foam Dressing Kit with FitPad - X-Large (3 pcs) SKU # 0876224.
The Invia Foam Dressing Kit with FitPad consists of a foam pad, a section interface (Invia FitPad) and Transparent Film (one or m Terminated |
OMP | K170088 |
| Dec 5, 2018 | Medela Inc Breast Milk Transfer Lid for use with Oral Syringe Connectors
Model: 90003S-100 Terminated |
FMF | K161811 |
| Jul 23, 2018 | Medela Inc Invia Motion Negative Pressure Wound Therapy System. Labeled as:
a. Endure Negative Pressure Wound Therapy (Model 087.4010);
b. 15 Days Negative Pressure Wound Therapy (Model 087.4012);
c. 60 Terminated |
OMP | K161128 |
| Sep 8, 2011 | Medela Inc Wound Dressing Kit - Tier I, 10 MM Flat Drain; product code 0877061.
Medela Healthcare,
McHenry, IL 60051;
A Wound Drain Kit containing a 10 mm Flat Drain, antimicrobial gauze pad, non-adherent wou Terminated |
MCY | K080357 |
| Jun 10, 2011 | Medela Inc Contact Nipple Shield (Sterile) - 24mm (Standard); Individually wrapped silicone contact nipple shields for immediate use for latch-on difficulties while breastfeeding the baby under professional care Terminated |
HFS | None listed |
| May 27, 2011 | Medela Inc AC Power Adaptor (transformer), TENPAO Model U090100Q31; used with the Pump In Style Advanced family of breast pumps; Medela Inc., McHenry, IL 60051-0650; Made in China; Article #9207010.
Converting Terminated |
OHH | K950750 |
| Feb 11, 2011 | Medela Inc Pump in Style Advanced (PNSA)Breast Pump; a daily use, double pump, electric powered breast pump; Manufactured exclusively by and for Medela, Inc., P.O. Box 660, 1101 Corporate Drive, McHenry, IL 6005 Terminated |
HGX | K031614 |
| Sep 24, 2010 | Medela Inc Sterile single/double breast personal accessory convenience kit for the Lactina Breast pump; the kit connects to a hospital grade breast pump for the removal, collection, and storage of mother's breas Terminated |
HGX | K875300 |
| Sep 24, 2010 | Medela Inc Sterile single/double breast personal accessory convenience kit for single or double pumping with a Classic Breast pump; the kit connects to a hospital grade breast pump for the removal, collection, a Terminated |
HGX | K801862 K823840 +1 |
| Sep 24, 2010 | Medela Inc Sterile double breast personal accessory convenience kit for the Symphony or Lactina Breast pumps; the kit connects to a hospital grade breast pump for the removal, collection, and storage of mother's Terminated |
HGX | K020518 K875300 |
| Sep 24, 2010 | Medela Inc Sterile double breast personal accessory convenience kit for the Symphony Breast pump; the kit connects to a hospital grade breast pump for the removal, collection, and storage of mother's breast milk Terminated |
HGX | K020518 |
| Apr 27, 2010 | Medela Inc Instruction for Use for Symphony Double Pumping Kit; Medela, Inc., P.O. Box 660, 1101 Corporate Drive, McHenry, IL 60051-0660; the instructions were packaged with the following non-sterile single user Terminated |
HGX | K020518 |