Medac, Inc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Medac, Inc.” (first 1987, latest 1988), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 71 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 | 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 |
|---|---|---|---|
| DRO | Pacemaker, Cardiac, External Transcutaneous (Non-Invasive) | 8 | 8 |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 1 | 1 |
| LDD | Dc-Defibrillator, Low-Energy, (Including Paddles) | 1 | 1 |
Review panels
- Cardiovascular (10)
Most recent Medac, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K874319 | MONITOR, ELECTROGRAPHIC | DRT | 1988-03-07 | 138 |
| K874447 | DISPOSABLE GEL DEFIBRILLATION/EXTERNAL PACING ELEC | DRO | 1988-01-27 | 91 |
| K874090 | 300M ECG MONITRO/TRANSCUTANEOUS PACEMAKER | DRO | 1987-12-15 | 69 |
| K874091 | 360D DC DEFIBRILLATOR | LDD | 1987-11-23 | 47 |
| K871176 | PACE 10 NON-INVASIVE EXTERNAL PACEMAKER | DRO | 1987-04-23 | 30 |
| K864985 | DISPOS GEL EXTERNAL PACING ELECTRODE/LOW IMPEDANCE | DRO | 1987-03-10 | 78 |
| K864989 | ETP 180A NON-INVASIVE EXTERNAL PACEMAKER | DRO | 1987-03-03 | 71 |
| K864988 | ETP 180E NON-INVASIVE EXTERNAL PACEMAKER | DRO | 1987-03-03 | 71 |
| K864987 | DISPOS GEL EXTERNAL PACING ELECTRODE/HI IMPEDANCE | DRO | 1987-03-03 | 71 |
| K864986 | ETP 300 NON-INVASIVE EXTERNAL PACEMAKER | DRO | 1987-03-03 | 71 |
Recalls
openFDA lists no recalls under a recalling firm named Medac, 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.
Device clinical trials
An industry sponsor named Medac, Inc. is the lead sponsor of 2 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT02052167: Human Factors Study of Methotrexate Prefilled Pen (50 mg/mL) in Patients With Juvenile Idiopathic Arthritis (Completed, started 2014-04)
- NCT01871961: Evaluation of Patient Performance Using the Metoject Device for Subcutaneous Injection in Rheumatoid Arthritis (RA)Patient (Completed, started 2012-10)
Frequently asked questions
How many FDA 510(k) clearances are listed under Medac, Inc.?
FDA lists 10 510(k) clearances under the applicant name “Medac, Inc.” (first 1987, latest 1988), 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 Medac, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medac, Inc. is 71 days.
Which FDA product codes appear under Medac, Inc.?
The most frequent FDA product codes under this applicant name are DRO (Pacemaker, Cardiac, External Transcutaneous (Non-Invasive), 8); DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm), 1); LDD (Dc-Defibrillator, Low-Energy, (Including Paddles), 1).
Next steps
- See all 10 Medac, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DRO, Medac, 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.