Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
JZH · Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
59 daysmedian FDA review time
93 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K964843 | IMMAGE IMMUNOCHEMISTRY SYSTEM PROPERDIN FACTOR B (PFB) REAGE | Beckman Instruments, Inc. | 1997-03-06 | 93 | 0 |
| K882623 | PROPERDIN FACTOR B FOR TECHNICON DPA-1(TM) SYSTEM | Technicon Instruments Corp. | 1988-07-08 | 14 | 0 |
| K831959 | RADIAL IMMUNO-TEST FOR HUMAN FACTOR B | Kent Laboratories, Inc. | 1983-07-19 | 32 | 0 |
| K811740 | KALLESTAD'S ENDOPLATE FACTOR B TEST | Kallestad Laboratories, Inc. | 1981-07-16 | 27 | 0 |
| K781016 | C3PA (GBG) PROPERDIN FACTOR B | Icl Scientific | 1978-08-14 | 59 | 0 |
| K772084 | LAS-R HUMAN C3 PROACTIVATOR TEST | Hyland Therapeutic Div., Travenol Laboratories | 1978-01-24 | 81 | 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