Dailycare Biomedical, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Dailycare Biomedical, Inc.” (first 2005, latest 2018), across 1 product code in 1 review panel. Median 510(k) review time under this name: 126 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 | 1 | 294 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Dailycare Biomedical, Inc. took a median 294 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 227 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DPS | Electrocardiograph | 5 | 5 |
Review panels
- Cardiovascular (5)
Most recent Dailycare Biomedical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K172778 | CheckMyHeart Plus | DPS | 2018-07-05 | 294 |
| K062894 | INSTANTCHECK RTD-ECG MONITOR, MODEL RMH4.0 | DPS | 2007-02-08 | 134 |
| K052303 | READMYHEART, MODEL RMH2.0 | DPS | 2005-12-16 | 114 |
| K050620 | READMYHEART, MODEL RMH3.0 | DPS | 2005-07-14 | 126 |
| K042814 | READMYHEART | DPS | 2005-01-06 | 86 |
Recalls
openFDA lists no recalls under a recalling firm named Dailycare Biomedical, Inc..
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 Dailycare Biomedical, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Dailycare Biomedical, Inc.” (first 2005, latest 2018), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Dailycare Biomedical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Dailycare Biomedical, Inc. is 126 days.
Which FDA product codes appear under Dailycare Biomedical, Inc.?
The most frequent FDA product codes under this applicant name are DPS (Electrocardiograph, 5).
Next steps
- See all 5 Dailycare Biomedical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DPS, Dailycare Biomedical, Inc.'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.