Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medical Graphics Corp. · Predicate Candidate Screening
23 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
78 daysmedian FDA review time
253 days90th percentile
23clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K152585 | Resmon PRO FULL | Medical Graphics Corp. | 2016-06-24 | 288 | 0 |
| K070858 | EXPRESS SERIES | Medical Graphics Corp. | 2007-04-16 | 19 | 0 |
| K061731 | MEDGRAPHICS ULTIMA SYSTEM | Medical Graphics Corp. | 2006-09-06 | 78 | 0 |
| K955432 | CPX, CCM, CATH WITH 15% CO2 | Medical Graphics Corp. | 1996-07-01 | 216 | 0 |
| K943259 | 1085 ULTIMATE E PLETHYSMOGRAPH | Medical Graphics Corp. | 1995-04-10 | 278 | 0 |
| K923209 | MEDGRAPHICS EXERCISE CONSULT | Medical Graphics Corp. | 1993-03-11 | 253 | 0 |
| K912906 | MEDGRAPHICS PF/DX | Medical Graphics Corp. | 1992-02-04 | 217 | 0 |
| K896345 | EXERCISE EVALUATION SYSTEM 2010 | Medical Graphics Corp. | 1990-01-20 | 78 | 0 |
| K896396 | MIDA SYSTEM, MODELS 1000/1100 | Medical Graphics Corp. | 1990-01-18 | 73 | 0 |
| K874925 | CPE 2000 CARDIO PULMONARY ERGOMETER | Medical Graphics Corp. | 1988-01-19 | 48 | 0 |
| K871711 | MEDICAL GRAPHICS DESKTOP DIAGNOSTIC SYSTEM | Medical Graphics Corp. | 1987-09-25 | 147 | 0 |
| K861929 | PULMONARY FUNCTION TEST LABORATORY, SYSTEM 1070 | Medical Graphics Corp. | 1986-09-26 | 129 | 0 |
| K861486 | SPIROMETRY MODULE | Medical Graphics Corp. | 1986-05-19 | 27 | 0 |
| K853848 | RESPIRATORY DIAGNOSTIC EQUIPMENT CALIBRATOR | Medical Graphics Corp. | 1985-12-05 | 80 | 0 |
| K852088 | SYSTEM 1085 BODY PLETHYSMOGRAPH | Medical Graphics Corp. | 1985-07-30 | 78 | 0 |
| K833756 | SYSTEM 5000 | Medical Graphics Corp. | 1984-04-24 | 181 | 0 |
| K822986 | PULMONARY FUNCTION LAB SYSTEM 1070 | Medical Graphics Corp. | 1982-11-16 | 35 | 0 |
| K820475 | MGC/LITTON 2300 | Medical Graphics Corp. | 1982-03-23 | 32 | 0 |
| K820476 | KEM-2 | Medical Graphics Corp. | 1982-03-08 | 17 | 0 |
| K812792 | PFT SCREENER (SYSTEM 1100) | Medical Graphics Corp. | 1981-11-27 | 52 | 0 |
| K801497 | INFANT VENTILATORY MEASUREMENT SYSTEM | Medical Graphics Corp. | 1980-10-03 | 99 | 0 |
| K801496 | PULMONARY LAB AUTOMATION SYSTEM | Medical Graphics Corp. | 1980-07-21 | 25 | 0 |
| K801495 | CARDIO-PULMONARY EXERCISE STRESS SYSTEM | Medical Graphics Corp. | 1980-07-21 | 25 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda