Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Graphic Controls Corp. — Predicate Candidate Screening
55 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
100 daysmedian FDA review time
232 days90th percentile
55clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K981964 | MEDI-TRACE 4103 NEONATAL ELECTRODE | Graphic Controls Corp. | 1998-11-13 | 162 | 0 |
| K983287 | MEDI-TRACE 1610C COMBINATION DEFIBRILLATION, MONITORING AND | Graphic Controls Corp. | 1998-11-05 | 48 | 0 |
| K974730 | SOFTRANS PLUS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 500 | Graphic Controls Corp. | 1998-07-14 | 208 | 0 |
| K980857 | MEDI-TRACE 1310P COMBINATION DEFIBRILLATION, MONITORING & PA | Graphic Controls Corp. | 1998-05-12 | 68 | 0 |
| K972970 | MEDI-TRACE 1510M COMBINATION DEFIBRILLATION, MONITORING AND | Graphic Controls Corp. | 1997-08-27 | 16 | 0 |
| K964387 | POINT OF USE II SHARPS-A-GATOR | Graphic Controls Corp. | 1997-03-27 | 143 | 0 |
| K964279 | SOFTRANS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 4000 SOF | Graphic Controls Corp. | 1997-01-22 | 86 | 0 |
| K963151 | MEDI-TRACE 5700 RESTING ECG ELECTRODE | Graphic Controls Corp. | 1996-11-19 | 102 | 0 |
| K963038 | MEDI-TRACE 3600 SERIES OF ECG MONITORING ELECTRODE | Graphic Controls Corp. | 1996-11-15 | 102 | 0 |
| K960968 | MEDI-TRACE 200, MEDI-TRACE 200-30 | Graphic Controls Corp. | 1996-10-28 | 231 | 0 |
| K955923 | MEDI-TRACE COMBINATION DEFIBRILLATION & ECG ELECTRODE FOR LA | Graphic Controls Corp. | 1996-10-24 | 301 | 0 |
| K955882 | MEDI-TRACE COMBINATION DEFIBRILLATION & ECG ELECTRODE FOR HE | Graphic Controls Corp. | 1996-10-24 | 301 | 2 |
| K955828 | MEDI-TRACE COMBINATION DEFIBRILLATION & ECG ELECTRODE FOR PH | Graphic Controls Corp. | 1996-07-25 | 212 | 0 |
| K955597 | MEDI-TRACE DEFIB PADS | Graphic Controls Corp. | 1996-07-09 | 214 | 0 |
| K961395 | MEDI-TRACE RADIOLUCENT | Graphic Controls Corp. | 1996-06-07 | 57 | 0 |
| K950498 | LIFE TRACE TRANS TIP INTRAUTERINE PRESSURE CATHETER | Graphic Controls Corp. | 1995-07-24 | 168 | 0 |
| K945479 | MEDI-TRACE(R) 500 ECG ELECTRODE | Graphic Controls Corp. | 1995-07-07 | 241 | 0 |
| K950485 | GRAPHIC CONTROLS PROTRACE ECG ELECTRODE | Graphic Controls Corp. | 1995-07-07 | 151 | 0 |
| K950489 | GRAPHIC CONTROLS BIOTAC JR. ECG ELECTRODE | Graphic Controls Corp. | 1995-07-03 | 147 | 0 |
| K950488 | GRAPHIC CONTROLS BIOTAC ECO ELECTRODE | Graphic Controls Corp. | 1995-07-03 | 147 | 0 |
| K950782 | MEDI-TRAC EEG ELECTRODE | Graphic Controls Corp. | 1995-06-22 | 121 | 0 |
| K950708 | LIFETRACE INTRAUTERINE PRESSURE CATHETER IUP 3000 | Graphic Controls Corp. | 1995-05-25 | 101 | 0 |
| K950487 | GRAPHIC CONTROLS Q-TRACE GOLD ECG ELECTRODE | Graphic Controls Corp. | 1995-05-17 | 100 | 0 |
| K950486 | GRAPHIC CONTROLS Q-TRACE ECG ELECTRODE | Graphic Controls Corp. | 1995-05-17 | 100 | 0 |
| K945214 | MEDI-TRACE NEONATAL ECG ELECTRODE WITH PREATTACHED LEADWIRE | Graphic Controls Corp. | 1994-11-10 | 16 | 0 |
| K943732 | LIFE TRACE FETAL SPIRAL ELECTRODE WITH MATERNAL REFERENCE | Graphic Controls Corp. | 1994-10-20 | 79 | 0 |
| K933365 | BABISTICK | Graphic Controls Corp. | 1993-10-19 | 102 | 0 |
| K926118 | LIFE TRACE(R) BILIRUBIN MASK | Graphic Controls Corp. | 1993-03-15 | 102 | 0 |
| K910742 | MEDI-TRACE DISPOSABLE INTRAUTERINE CATHETER | Graphic Controls Corp. | 1992-01-14 | 327 | 0 |
| K910418 | LIFE-TRACE DISPOSABLE LEG PLATE PRODUCT # LT-100 | Graphic Controls Corp. | 1991-07-16 | 167 | 0 |
| K910282 | MEDI-TRACE(R) DISPOSABLE TOCOTONOMETER | Graphic Controls Corp. | 1991-03-29 | 65 | 0 |
| K905130 | FETAL MONITORING SPIRAL ELECTRODE | Graphic Controls Corp. | 1991-01-29 | 75 | 0 |
| K904745 | MEDI-TRACE(R) FETAL MONITORING SPIRAL ELECTRODE | Graphic Controls Corp. | 1991-01-29 | 103 | 0 |
| K903973 | GARDOSI BIRTHING CUSHION | Graphic Controls Corp. | 1990-09-27 | 30 | 0 |
| K891193 | MEDI-TRACE ACCU-NATE DEVICE | Graphic Controls Corp. | 1989-09-19 | 197 | 0 |
| K891192 | MEDI-TRACE THERMAL VIDEO FILM PAPER | Graphic Controls Corp. | 1989-04-06 | 31 | 0 |
| K864722 | MEDI-TRACE INFANT ELECTRODE | Graphic Controls Corp. | 1987-02-10 | 69 | 0 |
| K843580 | MEDI-TRACE TRANSDUC PHYS PRESSURE MONITO | Graphic Controls Corp. | 1985-05-28 | 259 | 0 |
| K834445 | MEDI-TRACE QUIKSET DX DIAG. ELECT- | Graphic Controls Corp. | 1984-04-01 | 107 | 0 |
| K822750 | MEDI-TRACE 5' OFFSET ELECTRODE | Graphic Controls Corp. | 1982-11-01 | 49 | 0 |
| K821137 | MEDITRACE PELLET ELECTRODE | Graphic Controls Corp. | 1982-05-18 | 28 | 0 |
| K820457 | MEDI-TRACE PHYSIOLOGICAL PRESSURE TRANS | Graphic Controls Corp. | 1982-03-12 | 21 | 0 |
| K811410 | MEDI-TRACE | Graphic Controls Corp. | 1981-06-12 | 24 | 0 |
| K801828 | MEDI-TRACE DISP. STOPCOCKS/PHYSIO. PRESS | Graphic Controls Corp. | 1980-08-27 | 27 | 0 |
| K801829 | MEDI-TRACE DISP. FLUSHING DEV./MONITOR | Graphic Controls Corp. | 1980-08-27 | 27 | 0 |
| K801322 | MEDI-TRACE DISP. LINES FOR PHYSIO. PRESS | Graphic Controls Corp. | 1980-06-30 | 25 | 0 |
| K801321 | PACKAGE FOR MEDI-TRACE PHYSIOLOGICAL PRE | Graphic Controls Corp. | 1980-06-30 | 25 | 0 |
| K800706 | MEDI-TRACE DISPOSABLE DOMES/MONITORING | Graphic Controls Corp. | 1980-04-16 | 16 | 0 |
| K800705 | MEDI-TRACE TRANSDUCERS/PHYSIOLOG. MONITO | Graphic Controls Corp. | 1980-04-16 | 16 | 0 |
| K790818 | MEDI-TRACE EEG CREME | Graphic Controls Corp. | 1979-06-05 | 39 | 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