Current Health , Ltd.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Current Health , Ltd.” (first 2019, latest 2023), across 1 product code in 1 review panel. Median 510(k) review time under this name: 70 days. Since 2017 the median was 70 days, against 188 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 |
|---|---|---|
| 2019 | 2 | 65 |
| 2020 | 0 | — |
| 2021 | 1 | 227 |
| 2022 | 1 | 70 |
| 2023 | 1 | 92 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Current Health , Ltd. took a median 70 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 188 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MSX | System, Network And Communication, Physiological Monitors | 5 | 5 |
Review panels
- Cardiovascular (5)
Most recent Current Health , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K231506 | Current Health System | MSX | 2023-08-24 | 92 |
| K222550 | Current Health System | MSX | 2022-11-01 | 70 |
| K210133 | Current Health Monitoring System Gen 2 (G2) | MSX | 2021-09-03 | 227 |
| K191272 | Wearable Device, Wearable Package | MSX | 2019-07-12 | 60 |
| K190073 | Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case without Homehub | MSX | 2019-03-27 | 70 |
Recalls
openFDA lists no recalls under a recalling firm named Current Health , 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.
- Current Technologies, Inc. (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Current Health , Ltd.?
FDA lists 5 510(k) clearances under the applicant name “Current Health , Ltd.” (first 2019, latest 2023), 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 Current Health , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Current Health , Ltd. is 70 days. Since 2017: 70 days, versus 188 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Current Health , Ltd.?
The most frequent FDA product codes under this applicant name are MSX (System, Network And Communication, Physiological Monitors, 5).
Next steps
- See all 5 Current Health , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code MSX, Current Health , 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.