Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
OMG · Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K093815 | LIGHT DIAGNOSTICS HUMAN METAPNEUMOVIRUS DFA KIT, MODEL CATAL | Millipore Corporation | 2010-03-12 | 88 | 0 |
| K093233 | D3 FASTPOINT L-DFA RSV/MVP IDENTIFICATION KIT | Diagnostic Hybrids, Inc. | 2009-12-04 | 51 | 0 |
| K091171 | D3 ULTRA DUET DFA RESPIRATORY VIRUS IDENTIFICATION KIT | Diagnostic Hybrids, Inc. | 2009-09-11 | 142 | 0 |
| K090073 | D3 DFA METAPNEUMOVIRUS IDENTIFICATION KIT | Diagnostic Hybrids, Inc. | 2009-03-06 | 53 | 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