Medstone Intl., Inc.: FDA filings under this applicant name
FDA lists 3 510(k) clearances under the applicant name “Medstone Intl., Inc.” (first 1991, latest 2002), plus 2 PMA decisions, across 4 product codes in 2 review panels. Median 510(k) review time under this name: 73 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 |
|---|---|---|---|
| LNS | Lithotriptor, Extracorporeal Shock-Wave, Urological | 2 | 1 |
| IZF | System, X-Ray, Tomographic | 1 | 1 |
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | 1 | 1 |
| NCV | Lithotripter, Shockwave (For Treating Gallbladder Stones) | 1 | 0 |
Review panels
Most recent Medstone Intl., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K013620 | MEDSTONE, UROPRO 2000, TOMOGRAPHIC OPTION | IZF | 2002-01-22 | 78 |
| K010900 | STS-T LITHOTRIPTER, MODEL STS-T | LNS | 2001-04-05 | 10 |
| K905278 | STS(TM) FLUOROSCOPIC IMAGING MODULE | JAA | 1991-02-04 | 73 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P970042 | PMA | MEDSTONE STS LITHOTRIPTER | 2000-09-05 |
| P870015 | PMA | MEDSTONE 1050 ECTRACORPOREAL SHOCK WAVE LITHOTRIPT | 1988-04-15 |
Recalls
openFDA lists no recalls under a recalling firm named Medstone Intl., 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 Medstone Intl., Inc.?
FDA lists 3 510(k) clearances under the applicant name “Medstone Intl., Inc.” (first 1991, latest 2002), plus 2 PMA decisions, across 4 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 Medstone Intl., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medstone Intl., Inc. is 73 days.
Which FDA product codes appear under Medstone Intl., Inc.?
The most frequent FDA product codes under this applicant name are LNS (Lithotriptor, Extracorporeal Shock-Wave, Urological, 2); IZF (System, X-Ray, Tomographic, 1); JAA (System, X-Ray, Fluoroscopic, Image-Intensified, 1).
Next steps
- See all 3 Medstone Intl., Inc. clearances with predicates and recalls
- Run predicate analysis for product code LNS, Medstone Intl., 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.