Zoe Medical, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Zoe Medical, Inc.” (first 2001, latest 2021), across 3 product codes 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 | 1 | 126 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 390 |
| 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 Zoe Medical, Inc. took a median 390 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 174 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 2 | 2 |
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | 2 | 2 |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 1 | 1 |
Review panels
- Cardiovascular (5)
Most recent Zoe Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K200160 | 740 SafeSAT | MWI | 2021-02-15 | 390 |
| K130740 | NIGHTINGALE MONITORING SYSTEM | MWI | 2013-07-23 | 126 |
| K093802 | ULTRAVIEW DM3 MONITOR | DXN | 2010-04-09 | 119 |
| K040012 | WELL@HOME SYSTEM | DXN | 2004-04-02 | 88 |
| K001775 | ZOE MEDICAL NIGHTINGALE MONITORING SYSTEM | DRT | 2001-01-12 | 214 |
Recalls
4 product recalls in 3 recall events; 2 initiated in the last five years. Most recent: 2024-08-13.
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 Zoe Medical, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Zoe Medical, Inc.” (first 2001, latest 2021), across 3 product codes 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 Zoe Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Zoe Medical, Inc. is 126 days.
Which FDA product codes appear under Zoe Medical, Inc.?
The most frequent FDA product codes under this applicant name are DXN (System, Measurement, Blood-Pressure, Non-Invasive, 2); MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms), 2); DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm), 1).
Next steps
- See all 5 Zoe Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DXN, Zoe Medical, 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 (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.