Progeny, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Progeny, Inc.” (first 2002, latest 2009), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 34 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EHD | Unit, X-Ray, Extraoral With Timer | 2 | 2 |
| MUH | System, X-Ray, Extraoral Source, Digital | 2 | 2 |
| EIA | Unit, Operative Dental | 1 | 1 |
Review panels
Most recent Progeny, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K090079 | VIVID, MODELS 40-A0001, 40-A0004, 40-A0006 | EIA | 2009-05-01 | 109 |
| K070664 | PROGENY IMAGING SOFTWARE, MODEL# 500-405 (6,7,8). | MUH | 2007-04-26 | 48 |
| K043092 | PREVA, 76IN ARM, 66IN ARM, 56IN ARM, MODELS P7017, P7016, P7015 | EHD | 2004-12-13 | 34 |
| K041831 | PROGENY MPSE INTRAORAL DENTAL X-RAY SENSOR | MUH | 2004-08-09 | 33 |
| K020070 | JB-70 INTRAORAL X-RAY SYSTEM, MODELS 30-A0001/A0002 | EHD | 2002-02-01 | 23 |
Recalls
openFDA lists no recalls under a recalling firm named Progeny, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Progeny, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Progeny, Inc.” (first 2002, latest 2009), across 3 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Progeny, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Progeny, Inc. is 34 days.
Which FDA product codes appear under Progeny, Inc.?
The most frequent FDA product codes under this applicant name are EHD (Unit, X-Ray, Extraoral With Timer, 2); MUH (System, X-Ray, Extraoral Source, Digital, 2); EIA (Unit, Operative Dental, 1).
Next steps
- See all 5 Progeny, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EHD, Progeny, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.