Medicomp, Inc.: FDA filings under this applicant name
FDA lists 23 510(k) clearances under the applicant name “Medicomp, Inc.” (first 1983, latest 2018), across 12 product codes in 3 review panels. Median 510(k) review time under this name: 89 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 | 1 | 162 |
| 2017 | 0 | — |
| 2018 | 1 | 103 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 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 Medicomp, Inc. took a median 103 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 157 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DSI | Detector And Alarm, Arrhythmia | 7 | 7 |
| BZA | Connector, Airway (Extension) | 2 | 2 |
| CAI | Circuit, Breathing (W Connector, Adaptor, Y Piece) | 2 | 2 |
| DQK | Computer, Diagnostic, Programmable | 2 | 2 |
| DRG | Transmitters And Receivers, Physiological Signal, Radiofrequency | 2 | 2 |
| DXH | Transmitters And Receivers, Electrocardiograph, Telephone | 2 | 2 |
| BYD | Condenser, Heat And Moisture (Artificial Nose) | 1 | 1 |
| BYL | Tent, Oxygen | 1 | 1 |
| BZD | Ventilator, Non-Continuous (Respirator) | 1 | 1 |
| CAH | Filter, Bacterial, Breathing-Circuit | 1 | 1 |
Plus 2 more product codes.
Review panels
- Cardiovascular (15)
- Anesthesiology (7)
- General Hospital (1)
Most recent Medicomp, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K173170 | Epicardia Anywhere | DSI | 2018-01-10 | 103 |
| K161916 | TelePatch Cardiac Monitor | DRG | 2016-12-21 | 162 |
| K091696 | SAVI WIRELESS, MODEL PM500 | DRG | 2009-10-26 | 138 |
| K090834 | EPICARDIA 5000 | DSI | 2009-05-15 | 49 |
| K043454 | CARDIOPAL AI WITH DIOGENES SV (CARDIOPAL SV), MODEL PM410 | MLO | 2005-03-24 | 99 |
| K981119 | CARDIOPAL MODEL NUMBER PM20 | DXH | 1998-10-14 | 201 |
| K952846 | EPICARDIA | DQK | 1995-09-18 | 89 |
| K943915 | HEAT AND MOISTURE EXCHANGER FILTER (HME) | BYD | 1994-10-14 | 64 |
| K900207 | EPICARDIA 4000 | DST | 1990-07-31 | 196 |
| K883103 | EPICARDIA PC/FC | DSI | 1988-09-22 | 62 |
13 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Medicomp, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Medicomp, Inc.?
FDA lists 23 510(k) clearances under the applicant name “Medicomp, Inc.” (first 1983, latest 2018), across 12 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Medicomp, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medicomp, Inc. is 89 days.
Which FDA product codes appear under Medicomp, Inc.?
The most frequent FDA product codes under this applicant name are DSI (Detector And Alarm, Arrhythmia, 7); BZA (Connector, Airway (Extension), 2); CAI (Circuit, Breathing (W Connector, Adaptor, Y Piece), 2).
Next steps
- See all 23 Medicomp, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DSI, Medicomp, 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.