Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
JCN — Predicate Candidate Screening
12 FDA 510(k) clearances under this product code; the 50 most recent screened below.
42 daysmedian FDA review time
84 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K993825 | PARA TECH PLUS RETICS | Streck Laboratories, Inc. | 1999-11-30 | 18 | 3 |
| K942209 | LIQUICHEK HEMATOLOGY-16 CONTROL, LOW, NORMAL AND HIGH | Bio-Rad | 1994-06-16 | 42 | 0 |
| K934497 | CBC-STK(TM) HEMATOLOGY CONTROL/MULTIPLE | R&D Systems, Inc. | 1993-12-06 | 83 | 0 |
| K911582 | STAK-CHEX | Streck Laboratories, Inc. | 1991-05-28 | 50 | 0 |
| K902391 | CELL-DYN 3000 CONTROL | Unipath , Ltd. | 1990-08-22 | 84 | 0 |
| K902389 | TRI-COUNT 16 | Hematronix, Inc. | 1990-08-22 | 84 | 0 |
| K901875 | PARA 12 PLUS | Streck Laboratories, Inc. | 1990-05-30 | 34 | 0 |
| K896154 | PARA TECH FOR TECHNICON H-1 | Streck Laboratories, Inc. | 1989-11-09 | 16 | 0 |
| K895373 | HEMATOLOGY CONTROL | Medical Specialties Intl., Inc. | 1989-10-06 | 38 | 0 |
| K891907 | QBC(R) CENTRIFUGAL HEMATOLOGY CONTR/MULTI MODIFIED | R&D Systems, Inc. | 1989-04-11 | 15 | 0 |
| K874386 | CBC-TECH(TM) HEMATOLOGY CONTROL/MULTIPLE | R&D Systems, Inc. | 1987-12-30 | 65 | 0 |
| K821956 | HAEM-C PLUS BLOOD REFERENCE CONTROLS | Baker Instructions Corp. | 1982-07-30 | 30 | 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