Ardo Medical AG: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Ardo Medical AG” (first 2001, latest 2023), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 101 days. Since 2017 the median was 145 days, against 147 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 | 0 | — |
| 2013 | 0 | — |
| 2014 | 1 | 112 |
| 2015 | 1 | 90 |
| 2016 | 0 | — |
| 2017 | 1 | 145 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 227 |
| 2023 | 1 | 27 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Ardo Medical AG 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 147 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HGX | Pump, Breast, Powered | 5 | 5 |
| BTA | Pump, Portable, Aspiration (Manual Or Powered) | 1 | 1 |
Review panels
Most recent Ardo Medical AG 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K230590 | ARDO Bellis | HGX | 2023-03-30 | 27 |
| K212773 | ARDO Alyssa | HGX | 2022-04-15 | 227 |
| K172067 | One Mum Pumpset | HGX | 2017-11-29 | 145 |
| K150721 | ARDO Calypso Pro Powered Breast Pump | HGX | 2015-06-17 | 90 |
| K141742 | ARDO CARUM AND CALYPSO POWERED BREAST PUMPS | HGX | 2014-10-17 | 112 |
| K011601 | ARDO SUCTION PUMP MASTER, MODEL 30.00.XX; ARDO SUCTION PUMP SENATOR, MODEL 31.00.XX | BTA | 2001-06-08 | 15 |
Recalls
openFDA lists no recalls under a recalling firm named Ardo Medical 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Ardo Medical AG?
FDA lists 6 510(k) clearances under the applicant name “Ardo Medical AG” (first 2001, latest 2023), across 2 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 Ardo Medical AG?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ardo Medical AG is 101 days. Since 2017: 145 days, versus 147 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Ardo Medical AG?
The most frequent FDA product codes under this applicant name are HGX (Pump, Breast, Powered, 5); BTA (Pump, Portable, Aspiration (Manual Or Powered), 1).
Next steps
- See all 6 Ardo Medical AG clearances with predicates and recalls
- Run predicate analysis for product code HGX, Ardo Medical 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.