Medical Graphics Corp.: FDA filings under this applicant name
FDA lists 25 510(k) clearances under the applicant name “Medical Graphics Corp.” (first 1980, latest 2024), across 11 product codes in 3 review panels. Median 510(k) review time under this name: 78 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 | 288 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 1 | 269 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 30 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Medical Graphics Corp. took a median 150 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 230 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| BZM | Calculator, Pulmonary Function Interpretor (Diagnostic) | 7 | 7 |
| BTY | Calculator, Predicted Values, Pulmonary Function | 4 | 4 |
| BZL | Computer, Oxygen-Uptake | 4 | 4 |
| BZC | Calculator, Pulmonary Function Data | 2 | 2 |
| CCM | Plethysmograph, Pressure | 2 | 2 |
| BXB | Exerciser, Powered | 1 | 1 |
| BXW | Calibrator, Volume, Gas | 1 | 1 |
| DXG | Computer, Diagnostic, Pre-Programmed, Single-Function | 1 | 1 |
| DYC | Vectorcardiograph | 1 | 1 |
| KRI | Accessory Equipment, Cardiopulmonary Bypass | 1 | 1 |
Plus 1 more product codes.
Review panels
- Anesthesiology (21)
- Cardiovascular (3)
- Physical Medicine (1)
Most recent Medical Graphics Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K242809 | Ascent Cardiorespiratory Diagnostic Software | BTY | 2024-10-17 | 30 |
| K181912 | Ascent Cardiorespiratory Diagnostic Software | BTY | 2019-04-12 | 269 |
| K152585 | Resmon PRO FULL | PNV | 2016-06-24 | 288 |
| K070858 | EXPRESS SERIES | BZL | 2007-04-16 | 19 |
| K061731 | MEDGRAPHICS ULTIMA SYSTEM | BZL | 2006-09-06 | 78 |
| K955432 | CPX, CCM, CATH WITH 15% CO2 | BZM | 1996-07-01 | 216 |
| K943259 | 1085 ULTIMATE E PLETHYSMOGRAPH | CCM | 1995-04-10 | 278 |
| K923209 | MEDGRAPHICS EXERCISE CONSULT | BZM | 1993-03-11 | 253 |
| K912906 | MEDGRAPHICS PF/DX | BZL | 1992-02-04 | 217 |
| K896345 | EXERCISE EVALUATION SYSTEM 2010 | BZM | 1990-01-20 | 78 |
15 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Medical Graphics Corp..
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Medical Analysis Systems, Inc. (107 510(k)s)
- Medical Components, Inc. (63 510(k)s)
- Medical Advances, Inc. (57 510(k)s)
- Medical Diagnostic Technologies, Inc. (57 510(k)s)
- Medical Devices, Inc. (49 510(k)s)
- Medical Device Technologies, Inc. (46 510(k)s)
- Medical Specialties, Inc. (40 510(k)s)
- Medical Device Inspection Co., Inc. (30 510(k)s)
- Medical Engineering Corp. (28 510(k)s)
- Medical Data Electronics (27 510(k)s)
- Medical Innovations Corp. (24 510(k)s)
- Medical Instrument Development Laboratories, Inc. (23 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Medical Graphics Corp.?
FDA lists 25 510(k) clearances under the applicant name “Medical Graphics Corp.” (first 1980, latest 2024), across 11 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 Medical Graphics Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medical Graphics Corp. is 78 days.
Which FDA product codes appear under Medical Graphics Corp.?
The most frequent FDA product codes under this applicant name are BZM (Calculator, Pulmonary Function Interpretor (Diagnostic), 7); BTY (Calculator, Predicted Values, Pulmonary Function, 4); BZL (Computer, Oxygen-Uptake, 4).
Next steps
- See all 25 Medical Graphics Corp. clearances with predicates and recalls
- Run predicate analysis for product code BZM, Medical Graphics Corp.'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.