Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
JOX · Predicate Candidate Screening
15 FDA 510(k) clearances under this product code; the 50 most recent screened below.
60 daysmedian FDA review time
118 days90th percentile
15clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K111339 | HEMOSTASIS MANAGMENT SYSTEM PLUS (HMS-PLUS) | Medtronic, Inc. | 2011-06-08 | 27 | 0 |
| K102953 | HEPARIN DOSE RESPONSE CARTRIDGE | Medtronic, Inc. | 2010-11-04 | 31 | 0 |
| K101271 | HEMOSTASIS MANAGEMENT SYSTEM PLUS (HMS PLUS ), MODEL 305 XX | Medtronic, Inc. | 2010-10-13 | 160 | 0 |
| K051040 | HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR | Medtronic Perfusion Systems | 2005-05-24 | 29 | 0 |
| K043080 | HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR | Medtronic Vascular | 2004-12-03 | 25 | 0 |
| K042070 | HEPARIN DOSE RESPONSE CARTRIDGE, MODEL 304-20 | Medtronic Vascular | 2004-10-01 | 60 | 0 |
| K993519 | RAPIDPOINT ACCENT, MODEL 2000, RAPIDPOINT COAG HEPARIN TITRA | Cardiovascular Diagnostics, Inc. | 2000-01-14 | 88 | 0 |
| K922031 | HMS PURPLE AND BLACK HEPARIN CARTRIDGES & CONTROL | Medtronic Hemotec, Inc. | 1992-07-21 | 81 | 0 |
| K911240 | HEPCON HMS WITH BODY SURFACE AREA CALCULATION | Hemotech, Inc. | 1991-07-17 | 118 | 0 |
| K894317 | HEMOTEC HEPCON HMS COAGULATION SYSTEM & ACCESS. | Hemotec, Inc. | 1989-09-05 | 53 | 1 |
| K854377 | HEMOTEC CV WHOLE BLOOD COAGULATION CONTROLS | Hemotec, Inc. | 1985-12-04 | 35 | 0 |
| K841021 | HEMOTEC, HEPCON/SYS B-10 HEPARIN/PROTAM | Hemotec, Inc. | 1984-05-25 | 74 | 0 |
| K830665 | HEPCOL SYSTEM B-10 & B-10-P | Hemotec, Inc. | 1983-06-08 | 97 | 0 |
| K813011 | HEPAQUANT | Streck Laboratories, Inc. | 1982-01-26 | 91 | 0 |
| K800161 | HEPCON/SYSTEM RC-10 | Hemotec, Inc. | 1980-03-19 | 55 | 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