Microlife Corp.: FDA filings under this applicant name
FDA lists 16 510(k) clearances under 2 spellings of the applicant name “Microlife Corp.” (first 2000, latest 2026), across 4 product codes in 4 review panels. Median 510(k) review time under this name: 104 days. Since 2017 the median was 117 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 | 0 | — |
| 2013 | 1 | 307 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 1 | 117 |
| 2026 | 2 | 192 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Microlife Corp. took a median 117 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 | 10 | 10 |
| FLL | Continuous Measurement Thermometer | 3 | 3 |
| BZH | Meter, Peak Flow, Spirometry | 2 | 2 |
| LHD | Device, Fertility Diagnostic, Proceptive | 1 | 1 |
Review panels
Most recent Microlife Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261082 | Microlife Wrist Blood Pressure Monitor , (Model BPHJG5-G) | DXN | 2026-07-23 | 113 |
| K253180 | Microlife Digital Peak Flow Meter, Model PF200B (PF200B) | BZH | 2026-06-23 | 270 |
| K251120 | Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP Progress (BP3T01-1B) | DXN | 2025-08-06 | 117 |
| K122013 | MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, CARDIO+ (BP4GAPO-2M) | DXN | 2013-05-13 | 307 |
| K080337 | MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL BP3MQ1-2D | DXN | 2008-05-13 | 95 |
| K073398 | MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3MK1-3 (BP W100) | DXN | 2007-12-20 | 17 |
| K073397 | MICROLIFE UPPER ARM MANUAL BLOOD PRESSURE MONITOR, MODEL BP3MR1-H (BP A50) | DXN | 2007-12-20 | 17 |
| K041411 | MICROLIFE UPPER ARM BLOOD PRESSURE MONITOR, MODEL BP-3BTO-AP | DXN | 2004-07-21 | 55 |
| K031024 | MICROLIFE ELECTRONIC PEAK FLOW MONITOR, MODEL PF-100 | BZH | 2003-11-14 | 228 |
| K030961 | MICROLIFE DIGITAL BASAL THERMOMETER, MODEL MT 1921 | LHD | 2003-09-12 | 169 |
6 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Microlife Corp..
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 Microlife Corp. is the lead sponsor of 2 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT00861354: Home Monitoring for Atrial Fibrillation Using a Microlife Blood Pressure Monitor (Completed, started 2009-03)
- NCT00502931: A Systematic Review on the Accuracy and Reliability the BodyGem/MedGem Metabolic Devices (Completed, started 2006-11)
FDA spellings included
FDA records this applicant under 2 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- Microlife Corp. (13)
- Microlife Corporation (3)
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 Intellectual Property GmbH (54 510(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 Corp.?
FDA lists 16 510(k) clearances under 2 spellings of the applicant name “Microlife Corp.” (first 2000, latest 2026), across 4 product codes in 4 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 Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Microlife Corp. is 104 days. Since 2017: 117 days, versus 183 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Microlife Corp.?
The most frequent FDA product codes under this applicant name are DXN (System, Measurement, Blood-Pressure, Non-Invasive, 10); FLL (Continuous Measurement Thermometer, 3); BZH (Meter, Peak Flow, Spirometry, 2).
Next steps
- See all 16 Microlife Corp. clearances with predicates and recalls
- Run predicate analysis for product code DXN, Microlife Corp.'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.