Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LOS · Predicate Candidate Screening
83 FDA 510(k) clearances under this product code; the 50 most recent screened below.
189 daysmedian FDA review time
421 days90th percentile
83clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K090895 | EKG-PLUS II SOFTWARE | Bionet Co., Ltd. | 2009-08-26 | 149 | 0 |
| K083749 | CARDIOVIEW32 REVIEW MODULE | Qrs Diagnostic, LLC | 2009-03-10 | 83 | 0 |
| K073376 | PHILIPS ECG ALGORITHM | Philips Medical Systems | 2008-04-11 | 130 | 0 |
| K023034 | CARDIOTOUCH-3000 | Bionet Company, Ltd. | 2002-11-14 | 63 | 0 |
| K011328 | CARDIO CARE EKG-2000 12-CHANNEL ELECTROCARDIOGRAPH | Bionet Company, Ltd. | 2001-11-21 | 204 | 0 |
| K993616 | CARDIO-CARD INTERPRETATION SYSTEM I | Nasiff Assoc., Inc. | 2000-04-10 | 167 | 0 |
| K984465 | OXYCONALPHA WITH OPTION ECG | Erich Jaeger B.V. | 1999-10-27 | 315 | 0 |
| K991014 | CASE 8000 EXERCISE TESTING SYSTEM | General Electric Medical Systems Information Techn | 1999-10-20 | 208 | 0 |
| K991735 | MAC SERIES ELECTROCARDIOGRAPHS INCLUDING MAC 5000, MAC PC, M | General Electric Medical Systems Information Techn | 1999-08-19 | 90 | 0 |
| K990031 | NIHON KOHDEN ECG-9010K AND ECG-9020K CARDIOFAX GEM AND ACCES | Nihon Kohden America, Inc. | 1999-04-16 | 101 | 0 |
| K984504 | NIHON KOHDEN ECG-9110K AND ECG-9130K CARDIOFAX Q AND ACCESSO | Nihon Kohden America, Inc. | 1999-04-15 | 118 | 0 |
| K990266 | MICROMEDICAL 12 LEAD SIMULTANEOUS CABLE | Micromedical Industries, Ltd. | 1999-02-02 | 5 | 1 |
| K981024 | QT DISPERSION AND T WAVE ANALYSIS PROGRAM (QT GUARD ANALYSIS | Marquette Medical Systems, Inc. | 1998-10-06 | 201 | 0 |
| K974352 | CARDIOVIEW 3000 SOFTWARE | Micromedical, Inc. | 1998-09-08 | 293 | 0 |
| K981066 | FUKUDA DENSHI: CARDIOMAX, MODEL FX-4010 MULTI CHANNEL ELECTR | Fukuda Denshi USA, Inc. | 1998-08-31 | 160 | 0 |
| K972587 | ELECTROCARDIOGRAPHS | Dr. Lee Co., Ltd. | 1998-08-21 | 406 | 0 |
| K972255 | PULSE BIOMEDICAL INC, QRS CARD S-T SEGMENT ANALYSIS MONITORI | Pulse Biomedical, Inc. | 1998-07-07 | 385 | 0 |
| K981265 | PAGEWRITER 200I INTERPRETIVE CARDIOGRAPH MODEL M1770A WITH A | Hewlett-Packard Co. | 1998-06-23 | 77 | 0 |
| K974087 | MODEL M1792A THROMBOLYTIC PREDICTIVE INSTRUMENT | Hewlett-Packard Co. | 1998-06-15 | 229 | 0 |
| K973922 | ARCHIMED 4210 AND 4220 | Biosound Esaote, Inc. | 1998-05-12 | 209 | 0 |
| K980495 | MUSE CARDIOVASCULAR INFORMATION SYSTEM | Marquette Medical Systems, Inc. | 1998-05-07 | 87 | 0 |
| K973403 | CARDIOSMART ST | Marquette Medical Systems, Inc. | 1998-03-12 | 184 | 0 |
| K974199 | ACUTE CARDIAC ISCHEMIA TIME-INSENSITIVE PREDICTIVE INSTRUMEN | Marquette Medical Systems, Inc. | 1998-02-06 | 88 | 0 |
| K971440 | FUKUDA DENSHI MODEL FCP-2155 MULTI CHANNEL, INTERPRETIVE ELE | Fukuda Denshi USA, Inc. | 1997-12-02 | 228 | 0 |
| K970879 | CARDIOVIT CS-200 | Schiller America, Inc. | 1997-06-25 | 107 | 0 |
| K964750 | EAGLE 4000 PATIENT MONITOR | Marquette Electronics, Inc. | 1997-02-21 | 87 | 0 |
| K962854 | HARDWARE:CARDIO PERFECT PORTABLE, CARDIO PERFECT MD AND SOFT | Cardio Control BV | 1997-01-27 | 189 | 0 |
| K961223 | MULTIPLE PARAMETER TELEMETRY, VITAL VIEW, & MICROVIEW SYSTEM | Criticare Systems, Inc. | 1996-12-10 | 256 | 0 |
| K961272 | NIHON KOHDEN ECG-9320A CARDIOFAX AND ACCESSORIES | Nihon Kohden America, Inc. | 1996-11-01 | 213 | 0 |
| K961014 | QUINTON MODEL Q710 EXERCISE AND RESTING ELECTROCARDIOGRAPH | Quinton, Inc. | 1996-07-31 | 140 | 0 |
| K954980 | PAGEWRITER 200, 200I CARDIOGRAPH & INTERPRETIVE CARDIO | Hewlett-Packard Co. | 1996-05-15 | 197 | 0 |
| K946281 | ECLIPSE 4 ELECTROCARDIOGRAPH | Burdick, Inc. | 1996-04-23 | 483 | 0 |
| K951130 | CARDIOSOFT/CARDIOSYS | Marquette Electronics, Inc. | 1996-04-04 | 388 | 0 |
| K951978 | HEWLETT-PACKARD MODEL M1791A ACUTE CARDIAC ISCHEMIA-TIME INS | Hewlett-Packard Co. | 1996-01-04 | 252 | 0 |
| K953396 | CARDIOVIT AT-1C, AT-2C | Schiller America, Inc. | 1995-12-19 | 152 | 0 |
| K935589 | CENTRA HEART STATION | Marquette Electronics, Inc. | 1995-08-24 | 644 | 0 |
| K941282 | ECG FAX MODEM | Hewlett-Packard Co. | 1995-05-26 | 441 | 0 |
| K941462 | CARDIOVIT AT-5C | Schiller America, Inc. | 1995-05-19 | 421 | 0 |
| K943959 | ECLIPSE 4 ELECTROCARDIOGRAPH | Burdick, Inc. | 1995-05-17 | 275 | 0 |
| K935772 | HP M177XA CARDIOGRAPHS | Hewlett-Packard Co. | 1994-07-26 | 235 | 0 |
| K933143 | MODEL ELI 300 ELECTROCARDIOGRAPH | Mortara Instrument, Inc. | 1994-04-15 | 291 | 0 |
| K922394 | CARDIOFAX Q ECG-8420A | Nihon Kohden America, Inc. | 1994-03-01 | 650 | 0 |
| K923788 | SPACE LABS MODEL 90560 | Spacelabs, Inc. | 1993-12-06 | 496 | 0 |
| K922898 | CARDIO PERFECT, CARDIO PERFECT MD | Cardio Control BV | 1993-11-01 | 503 | 0 |
| K921669 | MARQUETTE SL SERIES TRANSPORT REMOTE ACQUISITION | Marquette Electronics, Inc. | 1993-05-07 | 394 | 0 |
| K922221 | SPRINT DX, MODEL 5400 EXERCISE STRESS TEST SYSTEM | Del Mar Avionics | 1993-04-21 | 344 | 0 |
| K915730 | MORTARA INSTRUMENT ODEL ELI 50I | Mortara Instrument, Inc. | 1992-11-10 | 326 | 0 |
| K914970 | CARDIOVIT CS-100 | Schiller America, Inc. | 1992-11-03 | 364 | 0 |
| K921476 | INTERP-1000 | Qmed, Inc. | 1992-10-21 | 205 | 0 |
| K915327 | ELITE II ELECTROCARDIOGRAPH,MODIFIED | Siemens Burdick, Inc. | 1992-10-09 | 318 | 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