Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
GKP — Predicate Candidate Screening
49 FDA 510(k) clearances under this product code; the 50 most recent screened below.
71 daysmedian FDA review time
256 days90th percentile
49clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K242127 | ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL | Instrumentation Laboratory (IL) Co. | 2024-08-16 | 28 | 0 |
| K231031 | ACL TOP Family 70 Series | Instrumentation Laboratory Company | 2023-06-21 | 71 | 0 |
| K160276 | ACL TOP (ACL TOP 700, ACL TOP 700 CTS, ACL TOP 700 LAS, ACL | Instrumentation Laboratory CO | 2016-03-03 | 30 | 1 |
| K150877 | ACL TOP FAMILY 50 SERIES: ACL TOP 350 CTS; ACL TOP 550 CTS; | Instrumentation Laboratory CO | 2015-12-13 | 256 | 1 |
| K091980 | ACL TOP 700 LAS | Instrumentation Laboratory CO | 2009-09-22 | 83 | 24 |
| K073377 | ACL TOP (WITH SYSTEM SOFTWARE V3.0.0) | Instrumentation Laboratory CO | 2008-05-04 | 153 | 0 |
| K063679 | ACL TOP | Instrumentation Laboratory CO | 2007-01-12 | 32 | 1 |
| K033414 | ACL TOP MODEL, TOP | Instrumentation Laboratory CO | 2004-01-12 | 77 | 1 |
| K031377 | SYSMEX AUTOMATED COAGULATION ANALYZER CA500 SERIES (CA-510, | Dade Behring, Inc. | 2003-09-08 | 130 | 0 |
| K023362 | FISHER DIAGNOSTICS THROMBOSCREEN 1000; PACIFIC HEMOSTASIS FI | Fisher Diagnostics | 2002-12-09 | 63 | 0 |
| K020979 | SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL #CA-7000 | Dade Behring, Inc. | 2002-06-27 | 93 | 0 |
| K001645 | SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500 | Dade Behring, Inc. | 2000-08-04 | 66 | 0 |
| K001891 | MICROSAMPLE COAGULATION ANALYZER, MODEL MCA 310-C | Bio/Data Corp. | 2000-07-12 | 21 | 0 |
| K001145 | SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000 | Dade Behring, Inc. | 2000-05-11 | 31 | 0 |
| K993299 | SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500 | Dade Behring, Inc. | 1999-12-07 | 67 | 0 |
| K993174 | SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000 | Dade Behring, Inc. | 1999-11-09 | 48 | 0 |
| K992423 | SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-500 | Dade Behring, Inc. | 1999-09-21 | 62 | 0 |
| K992763 | SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-500 | Dade Behring, Inc. | 1999-09-21 | 35 | 0 |
| K992321 | SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000 | Dade Behring, Inc. | 1999-09-17 | 67 | 0 |
| K991101 | COAG-A-MATE MAX | Organon Teknika Corp. | 1999-06-01 | 61 | 0 |
| K981206 | TAS RESULTS DATA ACQUISITION SYSTEM (TRAQS) | Cardiovascular Diagnostics, Inc. | 1998-05-26 | 55 | 0 |
| K964139 | SYSMEX CA-6000 | Dade Intl., Inc. | 1997-02-06 | 114 | 0 |
| K962857 | COAG-A-MATE MTX | Organon Teknika Corp. | 1997-01-22 | 184 | 0 |
| K962664 | ELECTRA 1800C AUTOMATIC COAGULATION ANALYZER | Medical Laboratory Automation Systems, Inc. | 1996-09-10 | 63 | 0 |
| K961991 | ACL 6000 SYSTEM (ACL 6000) | Instrumentation Laboratory CO | 1996-09-04 | 106 | 0 |
| K961579 | STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER | American Bioproducts Co. | 1996-07-10 | 77 | 3 |
| K954437 | THROMBELASTOGRAPH COAGULATION ANALYZER 3000S | Haemoscope Corp. | 1996-01-30 | 130 | 0 |
| K951072 | PROTIME MICROCOAGULATION SYSTEM | International Technidyne Corp. | 1995-10-27 | 233 | 2 |
| K943153 | MICROSAMPLE COAGULATION ANALYZER | Bio/Data Corp. | 1995-03-24 | 267 | 0 |
| K944227 | ELECTRA 1400C AUTOMATIC COAGULATION ANALYZER | Medical Laboratory Automation Systems, Inc. | 1995-02-03 | 155 | 0 |
| K942117 | STA AUTOMATED MULTI-PARAMETRIC ANALYZER | American Bioproducts Co. | 1995-02-01 | 274 | 0 |
| K931992 | HEMOLAB | Biomerieux Vitek, Inc. | 1994-12-22 | 608 | 0 |
| K933092 | TAS ANALYZER | Cardiovascular Diagnostic Services | 1993-11-15 | 144 | 0 |
| K931956 | CASCADE M, CAT. NO. 1710 | Helena Laboratories | 1993-08-23 | 125 | 0 |
| K931206 | ELECTRA 1600C AUTOMATIC COAGULATION TIMER | Medical Laboratory Automation Systems, Inc. | 1993-08-23 | 166 | 0 |
| K924098 | IL MCL-2 COAGULATION ANALYZER | Instrumentation Laboratory CO | 1993-06-18 | 309 | 0 |
| K921465 | CAT. NO. 1471 (110V) & CAT. NO. 1472 (220V) | Helena Laboratories | 1992-06-29 | 94 | 0 |
| K921363 | CASCADE 480 | Helena Laboratories | 1992-06-09 | 81 | 0 |
| K914946 | CASCADE 480(TM) AUTO COAG ANALYZER, MODIFICATION | Helena Laboratories | 1992-01-13 | 76 | 0 |
| K904297 | ST-4 COAGULATION INSTRUMENT | American Bioproducts Co. | 1990-11-13 | 55 | 0 |
| K904204 | THROMBELASTOGRAPH | Haemoscope Corp. | 1990-11-01 | 50 | 0 |
| K901380 | CASCADE 480(TM) AUTOMATED COAGULATION ANALY. 1430 | Helena Laboratories | 1990-05-25 | 64 | 0 |
| K901120 | KOAGULAB 60-S COAGULATION SYSTEM | Ortho Diagnostic Systems, Inc. | 1990-05-22 | 71 | 0 |
| K895844 | THROMBELASTOGRAPH(R) | Haemoscope Corp. | 1989-10-24 | 21 | 0 |
| K894052 | ELECTRA 1000C AUTOMATIC COAGULATION TIMER | Medical Laboratory Automation Systems, Inc. | 1989-07-27 | 50 | 0 |
| K884863 | ELECTRA 900C AUTOMATIC COAGULATION TIMER | Medical Laboratory Automation Systems, Inc. | 1989-02-03 | 74 | 0 |
| K885035 | KOAGULAB* 32-S COAGULATION SYSTEM | Ortho Diagnostic Systems, Inc. | 1989-02-03 | 60 | 0 |
| K881281 | COAG-A-MATE(R) XM | Organon Teknika Corp. | 1988-05-18 | 54 | 0 |
| K813564 | COAG-A-MATE X2 | General Diagnostics | 1982-01-28 | 37 | 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