Harvard Medical Devices , Ltd.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Harvard Medical Devices , Ltd.” (first 2008, latest 2010), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 119 days. 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 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 3 | 3 |
| FLL | Continuous Measurement Thermometer | 2 | 2 |
Review panels
- Cardiovascular (3)
- General Hospital (2)
Most recent Harvard Medical Devices , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K100620 | FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR , MODEL KN-550 | DXN | 2010-07-02 | 120 |
| K092558 | WRIST TYPE BLOOD PRESSURE MONITOR, HMBPM-005/KINETIK BRANDED BPM2 SERIES | DXN | 2010-03-17 | 209 |
| K092557 | DIGITAL THERMOMETER,HMCDT-002/KINETIK BRANDED DT1 SERIES | FLL | 2009-12-17 | 119 |
| K081159 | HARVARD MEDICAL DEVICES BLOOD PRESSURE MONITOR, MODEL HMBPM-004/KINETIK BRANDED BPM1 SERIES | DXN | 2008-08-08 | 116 |
| K081061 | HARVARD MEDICAL DEVICES IR EAR THERMOMETER, MODELS HMIRET-002 AND KINETIK BRANDED IET1 SERIES | FLL | 2008-07-18 | 95 |
Recalls
openFDA lists no recalls under a recalling firm named Harvard Medical Devices , Ltd..
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.
- Harvard Apparatus, Inc. (9 510(k)s)
- Harvard Laboratories (8 510(k)s)
- Harvard Clinical Technology (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Harvard Medical Devices , Ltd.?
FDA lists 5 510(k) clearances under the applicant name “Harvard Medical Devices , Ltd.” (first 2008, latest 2010), 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 Harvard Medical Devices , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Harvard Medical Devices , Ltd. is 119 days.
Which FDA product codes appear under Harvard Medical Devices , Ltd.?
The most frequent FDA product codes under this applicant name are DXN (System, Measurement, Blood-Pressure, Non-Invasive, 3); FLL (Continuous Measurement Thermometer, 2).
Next steps
- See all 5 Harvard Medical Devices , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code DXN, Harvard Medical Devices , Ltd.'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.