Microlife Intellectual Property GmbH: FDA filings under this applicant name
FDA lists 54 510(k) clearances under the applicant name “Microlife Intellectual Property GmbH” (first 2003, latest 2023), across 3 product codes in 3 review panels. Median 510(k) review time under this name: 78 days. Since 2017 the median was 195 days, against 183 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 | 2 | 133 |
| 2013 | 1 | 28 |
| 2014 | 1 | 116 |
| 2015 | 3 | 26 |
| 2016 | 1 | 112 |
| 2017 | 3 | 176 |
| 2018 | 2 | 235 |
| 2019 | 3 | 100 |
| 2020 | 3 | 133 |
| 2021 | 2 | 196 |
| 2022 | 1 | 265 |
| 2023 | 3 | 198 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Microlife Intellectual Property GmbH took a median 195 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 183 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 33 | 33 |
| FLL | Continuous Measurement Thermometer | 20 | 20 |
| BZH | Meter, Peak Flow, Spirometry | 1 | 1 |
Review panels
- Cardiovascular (33)
- General Hospital (20)
- Anesthesiology (1)
Most recent Microlife Intellectual Property GmbH 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K230075 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KVl-5K | DXN | 2023-06-28 | 169 |
| K222979 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KV1-5W | DXN | 2023-05-19 | 233 |
| K222153 | Microlife Upper Arm Automatic Digital BPM, Model WatchBP Office Vascular (TWIN200 VSR) | DXN | 2023-02-03 | 198 |
| K211776 | Microlife Non-Contact Infrared Forehead Thermometer, Model FR1MF1-B (NC150 BT) | FLL | 2022-03-01 | 265 |
| K211288 | Microlife Wrist Watch Blood Pressure Monitor Model BP3GK1-4B | DXN | 2021-11-04 | 190 |
| K202729 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor | DXN | 2021-04-08 | 202 |
| K200738 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor | DXN | 2020-07-23 | 122 |
| K200297 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor | DXN | 2020-06-18 | 133 |
| K191829 | Microlife Non-Contact Infrared Forehead Thermometer | FLL | 2020-02-13 | 219 |
| K183663 | Microlife Digital Infrared Ear Thermometer | FLL | 2019-07-16 | 201 |
44 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Microlife Intellectual Property GmbH.
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.
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.
- Microlife Corp. (16 510(k)s)
- Microlife Intellectual Property GmbH, Switzerland (3 510(k)s)
- Microlife Intellectual Property Gmb (1 510(k)s)
- Microlife Systems AG (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Microlife Intellectual Property GmbH?
FDA lists 54 510(k) clearances under the applicant name “Microlife Intellectual Property GmbH” (first 2003, latest 2023), across 3 product codes in 3 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 Microlife Intellectual Property GmbH?
The median time from FDA receipt to decision across 510(k)s cleared under the name Microlife Intellectual Property GmbH is 78 days. Since 2017: 195 days, versus 183 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Microlife Intellectual Property GmbH?
The most frequent FDA product codes under this applicant name are DXN (System, Measurement, Blood-Pressure, Non-Invasive, 33); FLL (Continuous Measurement Thermometer, 20); BZH (Meter, Peak Flow, Spirometry, 1).
Next steps
- See all 54 Microlife Intellectual Property GmbH clearances with predicates and recalls
- Run predicate analysis for product code DXN, Microlife Intellectual Property GmbH'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.