Medela, Inc.: FDA clearances and approvals
Medela, Inc. has 26 FDA 510(k) clearances (first 1980, latest 2026), across 8 product codes in 4 review panels. Median 510(k) review time: 111 days. Since 2017 its median was 145 days, against 153 days for all cleared 510(k)s in the same product codes. openFDA lists 13 product recalls by a recalling firm named Medela, Inc.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 128 |
| 2017 | 1 | 229 |
| 2018 | 1 | 89 |
| 2019 | 0 | — |
| 2020 | 1 | 105 |
| 2021 | 1 | 149 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 228 |
| 2025 | 0 | — |
| 2026 | 3 | 141 |
Review time against the same product codes
Since 2017, Medela, Inc.'s cleared 510(k)s took a median 145 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 153 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HGX | Pump, Breast, Powered | 14 | 14 |
| HGY | Pump, Breast, Non-Powered | 3 | 3 |
| HDB | Extractor, Vacuum, Fetal | 2 | 2 |
| HFS | Shield, Nipple | 2 | 2 |
| LBI | Unit, Neonatal Phototherapy | 2 | 2 |
| BTA | Pump, Portable, Aspiration (Manual Or Powered) | 1 | 1 |
| LHB | Timer, Apgar | 1 | 1 |
| PNR | Enteral Syringes With Enteral Specific Connectors | 1 | 1 |
Review panels
- Obstetrics and Gynecology (19)
- General Hospital (5)
- Gastroenterology and Urology (1)
- General and Plastic Surgery (1)
Most recent Medela, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253510 | Freestyle Mini Hands-free | HGX | 2026-04-10 | 156 |
| K253149 | Motion InBra (YM-8801) wearable breast pump | HGX | 2026-02-13 | 141 |
| K253498 | Pump In Style® Pro+ | HGX | 2026-01-22 | 85 |
| K232608 | Duo Hands-free Breast Pump | HGX | 2024-04-12 | 228 |
| K210759 | Solo, Swing Maxi | HGX | 2021-08-11 | 149 |
| K200508 | Pump In Style | HGX | 2020-06-15 | 105 |
| K181937 | Pump In Style Advanced, Advanced Personal Double Breastpump | HGX | 2018-10-16 | 89 |
| K161811 | Medela Low Dose Enteral Syringe | PNR | 2017-02-15 | 229 |
| K161725 | Sonata Breastpump Deluxe, Sonata Warranty Breastpump, Double pumping Tubing Kit, retail, Connector spare parts kit, Silicone Membrane, retail, Power Adaptor, retail | HGX | 2016-10-28 | 128 |
| K031614 | MEDELA PUMP IN STYLE ADVANCED BREAST PUMP | HGX | 2003-06-06 | 14 |
16 earlier clearances. See the full list in Caduvo.
Recalls
13 product recalls in 10 recall events; 1 initiated in the last five years. Most recent: 2026-06-05.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Medela, Inc. have?
Medela, Inc. has 26 FDA 510(k) clearances (first 1980, latest 2026), across 8 product codes in 4 review panels.
How long does FDA take to clear Medela, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Medela, Inc.'s cleared 510(k)s is 111 days. Since 2017: 145 days, versus 153 days for all cleared 510(k)s in the same product codes.
What devices does Medela, Inc. make?
Its most frequent FDA product codes are HGX (Pump, Breast, Powered, 14); HGY (Pump, Breast, Non-Powered, 3); HDB (Extractor, Vacuum, Fetal, 2).
Has Medela, Inc. had device recalls?
openFDA lists 13 product recalls in 10 recall events by a recalling firm whose name matches Medela, Inc; the most recent began 2026-06-05. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 26 Medela, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HGX, Medela, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.