Schoelly Fiberoptic GmbH: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Schoelly Fiberoptic GmbH” (first 1999, latest 2024), across 7 product codes in 5 review panels. Median 510(k) review time under this name: 127 days. Since 2017 the median was 266 days, against 118 days for all cleared 510(k)s in the same product codes. 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 | 2 | 154 |
| 2015 | 3 | 70 |
| 2016 | 1 | 267 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 85 |
| 2021 | 1 | 270 |
| 2022 | 0 | — |
| 2023 | 1 | 266 |
| 2024 | 1 | 266 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Schoelly Fiberoptic GmbH took a median 266 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 118 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EOB | Nasopharyngoscope (Flexible Or Rigid) | 3 | 3 |
| GCJ | Laparoscope, General & Plastic Surgery | 3 | 3 |
| HIH | Hysteroscope (And Accessories) | 2 | 2 |
| EIA | Unit, Operative Dental | 1 | 1 |
| FET | Endoscopic Video Imaging System/Component, Gastroenterology-Urology | 1 | 1 |
| FGA | Kit, Nephroscope | 1 | 1 |
| HET | Laparoscope, Gynecologic (And Accessories) | 1 | 1 |
Review panels
- Ear, Nose and Throat (3)
- Obstetrics and Gynecology (3)
- General and Plastic Surgery (3)
- Gastroenterology and Urology (2)
- Dental (1)
Most recent Schoelly Fiberoptic GmbH 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K233225 | SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope) | GCJ | 2024-06-20 | 266 |
| K221591 | Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope), NIR FI Light Source | GCJ | 2023-02-23 | 266 |
| K201617 | TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera Control Unit (CCU)) | HET | 2021-03-12 | 270 |
| K201970 | Schoelly Cystoscopes/Hysteroscopes and Accessories | HIH | 2020-10-08 | 85 |
| K151308 | Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set | FGA | 2016-02-09 | 267 |
| K150158 | Schoelly Cystoscopes/Hysteroscopes and Accessories | HIH | 2015-03-09 | 45 |
| K143673 | CMOS Video Nasopharyngoscope System | EOB | 2015-03-04 | 70 |
| K142249 | SCHOELLY SINUSCOPE | EOB | 2015-01-27 | 166 |
| K143221 | Schoelly Laparoscope | GCJ | 2014-12-05 | 25 |
| K132009 | CMOS VIDEO NASOPHARYNGOSCOPE SYSTEM | EOB | 2014-04-09 | 282 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Schoelly Fiberoptic GmbH.
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Schoelly Imaging, Inc. (5 510(k)s)
- Schoelly Technologies, Inc. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Schoelly Fiberoptic GmbH?
FDA lists 12 510(k) clearances under the applicant name “Schoelly Fiberoptic GmbH” (first 1999, latest 2024), across 7 product codes in 5 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 Schoelly Fiberoptic GmbH?
The median time from FDA receipt to decision across 510(k)s cleared under the name Schoelly Fiberoptic GmbH is 127 days. Since 2017: 266 days, versus 118 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Schoelly Fiberoptic GmbH?
The most frequent FDA product codes under this applicant name are EOB (Nasopharyngoscope (Flexible Or Rigid), 3); GCJ (Laparoscope, General & Plastic Surgery, 3); HIH (Hysteroscope (And Accessories), 2).
Next steps
- See all 12 Schoelly Fiberoptic GmbH clearances with predicates and recalls
- Run predicate analysis for product code EOB, Schoelly Fiberoptic GmbH'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.