Graphic Controls Corp.: FDA filings under this applicant name
FDA lists 55 510(k) clearances under the applicant name “Graphic Controls Corp.” (first 1977, latest 1998), across 18 product codes in 6 review panels. Median 510(k) review time under this name: 100 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 |
|---|---|---|---|
| DRX | Electrode, Electrocardiograph | 17 | 17 |
| MKJ | Automated External Defibrillators (Non-Wearable) | 6 | 6 |
| GYB | Media, Electroconductive | 5 | 5 |
| KXO | Monitor, Pressure, Intrauterine | 5 | 5 |
| DRS | Transducer, Blood-Pressure, Extravascular | 4 | 4 |
| HGP | Electrode, Circular (Spiral), Scalp And Applicator | 3 | 3 |
| DQO | Catheter, Intravascular, Diagnostic | 2 | 2 |
| GXY | Electrode, Cutaneous | 2 | 2 |
| KRA | Catheter, Continuous Flush | 2 | 2 |
| DTL | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | 1 | 1 |
Plus 8 more product codes.
Review panels
- Cardiovascular (32)
- Obstetrics and Gynecology (11)
- Neurology (7)
- General Hospital (3)
- Radiology (1)
- General and Plastic Surgery (1)
Most recent Graphic Controls Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K981964 | MEDI-TRACE 4103 NEONATAL ELECTRODE | DRX | 1998-11-13 | 162 |
| K983287 | MEDI-TRACE 1610C COMBINATION DEFIBRILLATION, MONITORING AND PACING ELECTRODE | MKJ | 1998-11-05 | 48 |
| K974730 | SOFTRANS PLUS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS PLUS IUPC) | KXO | 1998-07-14 | 208 |
| K980857 | MEDI-TRACE 1310P COMBINATION DEFIBRILLATION, MONITORING & PACING ELECTRODE | MKJ | 1998-05-12 | 68 |
| K972970 | MEDI-TRACE 1510M COMBINATION DEFIBRILLATION, MONITORING AND PACING ELECTRODE | MKJ | 1997-08-27 | 16 |
| K964387 | POINT OF USE II SHARPS-A-GATOR | MMK | 1997-03-27 | 143 |
| K964279 | SOFTRANS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 4000 SOFTRANS IUPC) | KXO | 1997-01-22 | 86 |
| K963151 | MEDI-TRACE 5700 RESTING ECG ELECTRODE | DRX | 1996-11-19 | 102 |
| K963038 | MEDI-TRACE 3600 SERIES OF ECG MONITORING ELECTRODE | DRX | 1996-11-15 | 102 |
| K960968 | MEDI-TRACE 200, MEDI-TRACE 200-30 | DRX | 1996-10-28 | 231 |
45 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Graphic Controls 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.
- Graphic Controls D.B.A. Vermed (0 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Graphic Controls Corp.?
FDA lists 55 510(k) clearances under the applicant name “Graphic Controls Corp.” (first 1977, latest 1998), across 18 product codes in 6 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 Graphic Controls Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Graphic Controls Corp. is 100 days.
Which FDA product codes appear under Graphic Controls Corp.?
The most frequent FDA product codes under this applicant name are DRX (Electrode, Electrocardiograph, 17); MKJ (Automated External Defibrillators (Non-Wearable), 6); GYB (Media, Electroconductive, 5).
Next steps
- See all 55 Graphic Controls Corp. clearances with predicates and recalls
- Run predicate analysis for product code DRX, Graphic Controls 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.