First Medical Devices Corp.: FDA clearances and approvals
First Medical Devices Corp. has 7 FDA 510(k) clearances (first 1986, latest 1990), across 3 product codes in 1 review panel. Median 510(k) review time: 53 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 |
|---|---|---|---|
| LDD | Dc-Defibrillator, Low-Energy, (Including Paddles) | 4 | 4 |
| MKJ | Automated External Defibrillators (Non-Wearable) | 2 | 2 |
| DRL | Tester, Defibrillator | 1 | 1 |
Review panels
- Cardiovascular (7)
Most recent First Medical Devices Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K903657 | MODEL 610 MODIFIED | LDD | 1990-09-04 | 26 |
| K895185 | FIRST MEDIC MODEL 610P | LDD | 1989-10-27 | 77 |
| K883584 | FIRST MEDIC MODE 610 | MKJ | 1988-10-06 | 45 |
| K880780 | HEARTSTART 2000 DEFIBRILLATOR TESTER, ECG | DRL | 1988-05-12 | 76 |
| K871136 | HEARTSTART 2000, MANUAL DEFIBRILLATOR | LDD | 1987-05-12 | 53 |
| K871135 | HEARTSTART 2000, MANUAL MEDICAL CONTROL MODULE | LDD | 1987-05-12 | 53 |
| K860676 | HEARTSTART 2000 | MKJ | 1986-04-30 | 64 |
Recalls
openFDA lists no recalls under a recalling firm named First Medical Devices Corp..
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 First Medical Devices Corp. have?
First Medical Devices Corp. has 7 FDA 510(k) clearances (first 1986, latest 1990), across 3 product codes in 1 review panel.
How long does FDA take to clear First Medical Devices Corp.'s 510(k)s?
The median time from FDA receipt to decision across First Medical Devices Corp.'s cleared 510(k)s is 53 days.
What devices does First Medical Devices Corp. make?
Its most frequent FDA product codes are LDD (Dc-Defibrillator, Low-Energy, (Including Paddles), 4); MKJ (Automated External Defibrillators (Non-Wearable), 2); DRL (Tester, Defibrillator, 1).
Has First Medical Devices Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching First Medical Devices Corp. Related entities may recall under other names.
Next steps
- See all 7 First Medical Devices Corp. clearances with predicates and recalls
- Run predicate analysis for product code LDD, First Medical Devices Corp.'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.