Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
GFO — Predicate Candidate Screening
52 FDA 510(k) clearances under this product code; the 50 most recent screened below.
79 daysmedian FDA review time
181 days90th percentile
52clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253957 | HemosIL Silica Clotting Time | Instrumentation Laboratory (IL) Co. | 2026-01-09 | 30 | 0 |
| K193556 | Cryocheck Hex LA | Precision Biologic | 2020-10-23 | 305 | 0 |
| K160445 | HemosIL Silica Clotting Time | Instrumentation Laboratory CO | 2016-03-16 | 28 | 0 |
| K053111 | STA-CEPHASCREEN KIT | Diagnostica Stago, Inc. | 2006-05-04 | 181 | 0 |
| K060688 | HEMOSIL SYNTHASIL | Instrumentation Laboratory CO | 2006-04-13 | 29 | 1 |
| K050221 | HEMOSIL SILICA CLOTTING TIME | Instrumentation Laboratory CO | 2005-03-30 | 58 | 0 |
| K022021 | VITAL SCIENTIFIC APTT, APTT & QUIKCOAG APTT | Vital Scientific N.V. | 2002-11-01 | 134 | 0 |
| K014028 | CARESIDE APTT | Careside Hemotology, Inc. | 2002-02-08 | 64 | 0 |
| K014008 | HEMOCHRON JR. CITRATE APTT CUVETTE | Itc, Inc. | 2002-01-24 | 50 | 1 |
| K992712 | SIGMA DIAGNOSTICS ALEXIN LS, MODELS A1219, A1334 | Sigma Diagnostics, Inc. | 1999-12-06 | 117 | 0 |
| K992711 | SIGMA DIAGNOSTICS ALEXIN HS, MODELS A0969, A1094 | Sigma Diagnostics, Inc. | 1999-12-06 | 117 | 0 |
| K972831 | HEMOCHRON CITRATE APTT | International Technidyne Corp. | 1997-11-20 | 113 | 0 |
| K973306 | IL TEST APTT-SP | Instrumentation Laboratory CO | 1997-11-04 | 62 | 0 |
| K961892 | SPECKTIN-LA TEST SET | Analytical Control Systems, Inc. | 1997-03-07 | 295 | 0 |
| K955638 | SYNTHAFAX APTT REAGENT | Ortho Diagnostic Systems, Inc. | 1996-04-23 | 134 | 1 |
| K955450 | PATHROMTIN SL | Behring Diagnostics, Inc. | 1996-04-19 | 142 | 1 |
| K953981 | SYNTHASIL APTT REAGENT | Ortho Diagnostic Systems, Inc. | 1995-11-30 | 99 | 0 |
| K935169 | APTT-ES | Helena Laboratories | 1994-12-02 | 402 | 0 |
| K934351 | APTT-ES REAGENT | Medical Diagnostic Technologies, Inc. | 1993-12-06 | 90 | 0 |
| K932011 | PATHROMTIN | Behring Diagnostics, Inc. | 1993-10-25 | 185 | 0 |
| K926012 | ACS APCT REAGENT, MODIFIED | Analytical Control Systems, Inc. | 1993-04-27 | 158 | 0 |
| K924637 | HEMOCHRON CITRA ONESTEP APTT/FAC VI SINGSHOT APTT | International Technidyne Corp. | 1993-01-27 | 148 | 0 |
| K924638 | HEMOCHRON DIRECT DRAW APTT/FAC VI VACU-APTT | International Technidyne Corp. | 1993-01-14 | 135 | 0 |
| K923731 | STACLOT LA TEST KIT | American Bioproducts Co. | 1992-12-23 | 149 | 1 |
| K921396 | PLATELIN L | Organon Teknika Corp. | 1992-10-19 | 210 | 0 |
| K921223 | ACS FREEZE-DRIED APTT REAGENT | Analytical Control Systems, Inc. | 1992-08-18 | 158 | 0 |
| K921118 | ACS APCT REAGENT | Analytical Control Systems, Inc. | 1992-07-28 | 141 | 0 |
| K915418 | ELLAGIC ACID APTT REAGENT | Helena Laboratories | 1992-02-14 | 74 | 0 |
| K915344 | HEMOCHRON ONESTEP APTT TEST | International Technidyne Corp. | 1992-02-11 | 77 | 0 |
| K911994 | HEMOCHRON(R) APTT, MODIFICATION | International Technidyne Corp. | 1991-07-17 | 86 | 0 |
| K903531 | ANTICARDIOLIPIN ANTIBODY TEST SYSTEM | Medical Innovations Corp. | 1991-01-25 | 172 | 0 |
| K905301 | THE THERATEST ACA TEST | Theratest Laboratories, Inc. | 1991-01-14 | 48 | 0 |
| K904341 | APTT REAGENT | Sigma Chemical Co. | 1990-11-08 | 49 | 0 |
| K902556 | ACS ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST | Analytical Control Systems, Inc. | 1990-08-06 | 59 | 0 |
| K900049 | APTT-EA REAGENT, AN ELLAGIC ACID ACTIVATED REAGENT | Medical Diagnostic Technologies, Inc. | 1990-01-25 | 22 | 0 |
| K896545 | ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) | Sigma Chemical Co. | 1989-12-01 | 14 | 0 |
| K895255 | APTT-P REAGENT, A PARTICLE ACTIVATED REAGENT | Medical Diagnostic Technologies, Inc. | 1989-10-06 | 46 | 0 |
| K892209 | APTT BY HEMOCHRON(R) | Intensive Technology, Inc. | 1989-06-22 | 80 | 0 |
| K891015 | COAG-1 APTT TEST CARD | Cardiovascular Diagnostic Services | 1989-05-22 | 83 | 0 |
| K891337 | THROMBOSCREEN APTT REAGENT | Pacific Hemostasis | 1989-04-21 | 42 | 0 |
| K890859 | EDL GLOBAL ACTIVATED PARTIAL THROMBOPLASTIN TIME | Elite Diagnostic , Ltd. | 1989-04-21 | 59 | 0 |
| K890619 | EDL ACTIVATED PARTIAL THROMBOPLASTIN TIME REAGENT | Elite Diagnostic , Ltd. | 1989-03-15 | 36 | 0 |
| K890052 | BIOTRACK APTT REAGENT CARTRIDGE | Biotrack, Inc. | 1989-02-24 | 49 | 0 |
| K884856 | APTT REAGENT | Precision Biologicals, Inc. | 1989-01-30 | 73 | 0 |
| K884702 | EASY-TEST PARTIAL THROMBOPLASTIN TIME PTT #16629 | Em Diagnostic Systems, Inc. | 1989-01-27 | 79 | 0 |
| K884485 | KD ACTIVATED PARTIAL THROMBOPLASTIN TIME REAGENT | King Diagnostics, Inc. | 1988-12-28 | 64 | 0 |
| K882325 | UNIFAST ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST | Sclavo, Inc. | 1988-08-25 | 80 | 0 |
| K881068 | CLP ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST | Creative Laboratory Products, Inc. | 1988-03-23 | 9 | 0 |
| K820835 | ALUMINA SILICA-ACTIVATED PARTIAL THROM | Hyland Therapeutic Div., Travenol Laboratories | 1982-04-26 | 31 | 0 |
| K781104 | PLASMA COAGULATION CONT., ABNORMAL | Ortho Diagnostics, Inc. | 1978-08-10 | 38 | 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