Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Progeny, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
34 daysmedian FDA review time
109 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K090079 | VIVID, MODELS 40-A0001, 40-A0004, 40-A0006 | Progeny, Inc. | 2009-05-01 | 109 | 0 |
| K070664 | PROGENY IMAGING SOFTWARE, MODEL# 500-405 (6,7,8). | Progeny, Inc. | 2007-04-26 | 48 | 0 |
| K043092 | PREVA, 76IN ARM, 66IN ARM, 56IN ARM, MODELS P7017, P7016, P7 | Progeny, Inc. | 2004-12-13 | 34 | 0 |
| K041831 | PROGENY MPSE INTRAORAL DENTAL X-RAY SENSOR | Progeny, Inc. | 2004-08-09 | 33 | 0 |
| K020070 | JB-70 INTRAORAL X-RAY SYSTEM, MODELS 30-A0001/A0002 | Progeny, Inc. | 2002-02-01 | 23 | 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