Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Digene Corp. — Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
183 daysmedian FDA review time
669 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K010891 | MODIFICATION TO HYBRID CAPTURE II CT/GC TEST, MODEL 03M90-01 | Digene Corp. | 2001-09-25 | 183 | 0 |
| K010892 | MODIFICATION HYBRID CAPTURE II CT-ID DNA TEST, MODEL 03M91-0 | Digene Corp. | 2001-09-24 | 182 | 0 |
| K010893 | MODIFICATION TO HYBRID CAPTURE 2 GC-ID DNA TEST, MODEL 03M92 | Digene Corp. | 2001-09-24 | 182 | 0 |
| K981567 | HYBRID CAPTURE II CT/GC TEST | Digene Corp. | 2000-02-29 | 669 | 0 |
| K981485 | HYBRID CAPTURE II GC-ID | Digene Corp. | 1999-11-29 | 584 | 0 |
| K990023 | HYBRID CAPTURE II CT-ID TEST | Digene Corp. | 1999-10-25 | 293 | 1 |
| K974901 | HYBRID CAPTURE SYSTEM CMV DNA ASSAY | Digene Corp. | 1998-09-29 | 272 | 0 |
| K980120 | DIGENE DML 2000 MICROPLATE LUMINOMETER | Digene Corp. | 1998-02-06 | 24 | 0 |
| K971586 | DIGENE CERVICAL BRUSH | Digene Corp. | 1997-09-19 | 141 | 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