Dart Medical Equipment: FDA clearances and approvals
Dart Medical Equipment has 7 FDA 510(k) clearances (first 1980, latest 1982), across 3 product codes in 1 review panel. Median 510(k) review time: 23 days.
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 |
|---|---|---|---|
| DXH | Transmitters And Receivers, Electrocardiograph, Telephone | 4 | 4 |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 2 | 2 |
| DTC | Analyzer, Pacemaker Generator Function | 1 | 1 |
Review panels
- Cardiovascular (7)
Most recent Dart Medical Equipment 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K820986 | EKG MONITORS, VARIOUS MODELS | DXH | 1982-04-29 | 23 |
| K820904 | EKG TELEPHONE CONVERTER | DXH | 1982-04-21 | 21 |
| K820828 | SAMM | DXH | 1982-04-14 | 19 |
| K803315 | CRITERION II RHYTHM PROFILE MONITOR | DXH | 1981-01-22 | 23 |
| K802782 | THE CRITERION II PACING SYS. MONITOR | DRT | 1980-11-19 | 16 |
| K802325 | CRITERION II PACING SYSTEM MONITORS | DRT | 1980-10-23 | 30 |
| K800286 | CRITERION II PACING SYSTEM MONITORS | DTC | 1980-03-12 | 33 |
Recalls
openFDA lists no recalls under a recalling firm named Dart Medical Equipment.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Dart Medical Equipment have?
Dart Medical Equipment has 7 FDA 510(k) clearances (first 1980, latest 1982), across 3 product codes in 1 review panel.
How long does FDA take to clear Dart Medical Equipment's 510(k)s?
The median time from FDA receipt to decision across Dart Medical Equipment's cleared 510(k)s is 23 days.
What devices does Dart Medical Equipment make?
Its most frequent FDA product codes are DXH (Transmitters And Receivers, Electrocardiograph, Telephone, 4); DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm), 2); DTC (Analyzer, Pacemaker Generator Function, 1).
Has Dart Medical Equipment had device recalls?
openFDA lists no recalls under a recalling firm name matching Dart Medical Equipment. Related entities may recall under other names.
Next steps
- See all 7 Dart Medical Equipment clearances with predicates and recalls
- Run predicate analysis for product code DXH, Dart Medical Equipment's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.