Medela AG: FDA filings under this applicant name
FDA lists 30 510(k) clearances under the applicant name “Medela AG” (first 2002, latest 2025), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 148 days. Since 2017 the median was 190 days, against 157 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 292 |
| 2013 | 2 | 156 |
| 2014 | 2 | 116 |
| 2015 | 5 | 141 |
| 2016 | 2 | 186 |
| 2017 | 1 | 86 |
| 2018 | 2 | 278 |
| 2019 | 2 | 146 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 208 |
| 2023 | 1 | 242 |
| 2024 | 0 | — |
| 2025 | 1 | 139 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Medela AG took a median 190 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 157 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OMP | Negative Pressure Wound Therapy Powered Suction Pump | 13 | 13 |
| BTA | Pump, Portable, Aspiration (Manual Or Powered) | 9 | 9 |
| HGX | Pump, Breast, Powered | 5 | 5 |
| QPB | System, Suction, Lipoplasty For Removal | 2 | 2 |
| HDB | Extractor, Vacuum, Fetal | 1 | 1 |
Review panels
Most recent Medela AG 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K251377 | Magic InBra | HGX | 2025-09-18 | 139 |
| K223388 | Invia® Integrated Dressing | OMP | 2023-07-07 | 242 |
| K214112 | Invia Ease Negative Pressure Wound Therapy (NPWT) System | OMP | 2022-07-26 | 208 |
| K191653 | Freestyle Flex | HGX | 2019-10-17 | 119 |
| K182191 | Invia Abdominal Dressing Kit | OMP | 2019-02-01 | 172 |
| K180415 | Invia White Foam NPWT | OMP | 2018-11-02 | 260 |
| K172145 | Invia Foam Dressing Kits With FitPad, Invia Motion Negative Pressure Wound Therapy System (Invia Motion - Endure, Invia Motion 120 days, Invia Motion 60 days, Invia Motion 30 days, Invia Motion 15 days, Invia Motion 7 days), Invia Liberty Negative Pressure Wound Therapy System, Invia Gauze Dressing Kits with FitPad | OMP | 2018-05-09 | 296 |
| K170088 | Invia Foam Dressing Kits with FitPad, Invia Foam Dressing Kits with FitPad, Invia Gauze Dressing Kits with FitPad, Invia FitPad, Invia Transparent Film | OMP | 2017-04-06 | 86 |
| K161128 | Invia Motion-Endure Negative Pressure Wound Therapy System, Invia Motion-7-120 Days Negative Pressure Wound Therapy System, Invia Motion Canister/Tubing Set 0.151, Invia Motion Carrying Case, Power Supply | OMP | 2016-12-01 | 224 |
| K153663 | Vario 8/18/ci | BTA | 2016-05-18 | 149 |
20 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Medela AG.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Medela AG is the lead sponsor of 8 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT04619212: Initiate Study Evaluating if Mothers Who Are Both Breastfeeding and Pumping in the First Days After Delivery Report Improved Comfort Levels With the New Symphony Program Card (Completed, started 2021-01-05)
- NCT04593693: A Dual-center Study Evaluating Clinical Acceptance of a NPWT Wound Care System (Completed, started 2020-12-10)
- NCT03921918: Evaluation of Fluid-Filled Expression Core Technology Study - I (Completed, started 2019-05-08)
- NCT03670225: Evaluating Clinical Acceptance of a NPWT Wound Care System (Completed, started 2018-10-16)
- NCT03091985: Influence of the Brownie Breast Shield on the Dynamics of Milk Removal (Completed, started 2017-03-31)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Medela, Inc. (26 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Medela AG?
FDA lists 30 510(k) clearances under the applicant name “Medela AG” (first 2002, latest 2025), across 5 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Medela AG?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medela AG is 148 days. Since 2017: 190 days, versus 157 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Medela AG?
The most frequent FDA product codes under this applicant name are OMP (Negative Pressure Wound Therapy Powered Suction Pump, 13); BTA (Pump, Portable, Aspiration (Manual Or Powered), 9); HGX (Pump, Breast, Powered, 5).
Next steps
- See all 30 Medela AG clearances with predicates and recalls
- Run predicate analysis for product code OMP, Medela AG's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.