Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
CFQ — Predicate Candidate Screening
12 FDA 510(k) clearances under this product code; the 50 most recent screened below.
38 daysmedian FDA review time
60 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K981786 | IGA MININEPH ANTISERUM | The Binding Site, Ltd. | 1999-11-24 | 553 | 0 |
| K990552 | IMMUNOGLOBULIN A TEST SYSTEM | Dade Behring, Inc. | 1999-03-25 | 31 | 0 |
| K990551 | IGG FLEX REAGENT CARTRIDGE | Dade Behring, Inc. | 1999-03-25 | 31 | 0 |
| K990553 | IGM FLEX REAGENT CARTRIDGE | Dade Behring, Inc. | 1999-03-22 | 28 | 0 |
| K951055 | OLYMPUS IGA IMMUNOTURBIDIMETRIC REAGENT | Olympus America, Inc. | 1995-04-17 | 41 | 0 |
| K951013 | OLYMPUS IGG IMMUNOTURBIDIMETRIC REAGENT | Olympus America, Inc. | 1995-04-17 | 42 | 0 |
| K950900 | OLYMPUS IGM IMMUNOTURBIDIMETRIC REAGENT | Olympus America, Inc. | 1995-03-27 | 27 | 0 |
| K891188 | TITAN GEL IFE TRIVALENT ANTISERUM | Helena Laboratories | 1989-03-22 | 16 | 0 |
| K890561 | SPQ(TM) ANTIBODY REAGENT SET II FOR IGM | Atlantic Antibodies | 1989-02-23 | 30 | 0 |
| K881928 | MONOCLONAL RADIAL IMMUNODIFFUSION KIT | The Binding Site, Ltd. | 1988-07-08 | 60 | 0 |
| K881827 | IMMUNOGLOBULIN A TEST SYSTEM | The Binding Site, Ltd. | 1988-06-10 | 42 | 0 |
| K881828 | IMMUNOGLOBULIN M TEST SYSTEM | The Binding Site, Ltd. | 1988-06-06 | 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