Schoelly Imaging, Inc.: FDA clearances and approvals
Schoelly Imaging, Inc. has 5 FDA 510(k) clearances (first 2006, latest 2009), across 5 product codes in 3 review panels. Median 510(k) review time: 67 days.
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 |
|---|---|---|---|
| EOB | Nasopharyngoscope (Flexible Or Rigid) | 1 | 1 |
| FAJ | Cystoscope And Accessories, Flexible/Rigid | 1 | 1 |
| FET | Endoscopic Video Imaging System/Component, Gastroenterology-Urology | 1 | 1 |
| FWF | Camera, Television, Endoscopic, Without Audio | 1 | 1 |
| NTN | Led Light Source | 1 | 1 |
Review panels
Most recent Schoelly Imaging, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K090800 | VS-100 ILLUMINATION AND IMAGING SYSTEM | FET | 2009-05-18 | 55 |
| K090601 | FSC 2 | NTN | 2009-05-11 | 67 |
| K083553 | NASO-LARYNGO-PHARYNGOSCOPE | EOB | 2009-01-16 | 46 |
| K060899 | FLEXILUX II CYSTOSCOPE AND HYSTEROSCOPE | FAJ | 2007-03-02 | 333 |
| K053412 | FLEXISCOPE, MODELS 50MH AND 50 MHC | FWF | 2006-02-23 | 78 |
Recalls
openFDA lists no recalls under a recalling firm named Schoelly Imaging, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Schoelly Imaging, Inc. have?
Schoelly Imaging, Inc. has 5 FDA 510(k) clearances (first 2006, latest 2009), across 5 product codes in 3 review panels.
How long does FDA take to clear Schoelly Imaging, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Schoelly Imaging, Inc.'s cleared 510(k)s is 67 days.
What devices does Schoelly Imaging, Inc. make?
Its most frequent FDA product codes are EOB (Nasopharyngoscope (Flexible Or Rigid), 1); FAJ (Cystoscope And Accessories, Flexible/Rigid, 1); FET (Endoscopic Video Imaging System/Component, Gastroenterology-Urology, 1).
Has Schoelly Imaging, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Schoelly Imaging, Inc. Related entities may recall under other names.
Next steps
- See all 5 Schoelly Imaging, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EOB, Schoelly Imaging, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.