Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
DAE · Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
191 daysmedian FDA review time
271 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K150412 | Optilite CH50 Reagent, Optilite CH50 Controls and Optilite C | The Binding Site Group , Ltd. | 2015-08-28 | 191 | 0 |
| K113349 | HUMAN CH50 REAGENT PACK FOR USE ON THE SPAPLUS, HUMAN CH50 C | The Binding Site Group , Ltd. | 2012-07-11 | 240 | 0 |
| K992488 | TOTAL HAEMOLYTIC COMPLEMENT RID KIT | The Binding Site, Ltd. | 1999-09-17 | 53 | 0 |
| K974111 | QUIDEL CH50 EQ EIA | Quidel Corp. | 1998-07-29 | 271 | 0 |
| K954145 | WAKO AUTOKIT CH50 | Wako Chemicals USA, Inc. | 1995-12-18 | 104 | 0 |
| K951639 | COMPLEMENT ACTIVATION EIA TEST SYSTEM (CAE) | Incstar Corp. | 1995-10-13 | 186 | 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