Fiberoptic Sensor Technlogies, Inc.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Fiberoptic Sensor Technlogies, Inc.” (first 1987, latest 1995), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 96 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 |
|---|---|---|---|
| FEN | Device, Cystometric, Hydraulic | 8 | 8 |
| DXO | Transducer, Pressure, Catheter Tip | 1 | 1 |
| EXY | Uroflowmeter | 1 | 1 |
| FAP | Cystometric Gas (Carbon-Dioxide) On Hydraulic Device | 1 | 1 |
Review panels
Most recent Fiberoptic Sensor Technlogies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K945753 | FST FIBEROPTIC PRESSURE CONVERTER | FEN | 1995-05-11 | 169 |
| K950908 | FST CATH-UD, CATHETER | FEN | 1995-04-07 | 50 |
| K945495 | 4-CHANNEL URODYNAMIC MONITOR WITH URO-FLO OPTION | EXY | 1995-02-09 | 93 |
| K930171 | FST DUAL, DUAL PRESSURE URODYNAMICS MONITOR | FEN | 1993-11-04 | 295 |
| K922776 | FST COUNCIL TIP FOLEY CATHETER | FEN | 1993-07-20 | 406 |
| K922476 | URO-PRO 2000 | FAP | 1993-07-20 | 420 |
| K926088 | FST CATH UD-DUAL DUAL PRESSURE CATHETER | FEN | 1993-06-18 | 198 |
| K913113 | FST CATH-UD CATHETER, MODIFICATION | FEN | 1991-10-09 | 96 |
| K913721 | FST CATH - UI USRODYNAMIC CATH INTRODUCER SYSTEM | FEN | 1991-10-08 | 49 |
| K905641 | FST CATH-UD CATHETER | FEN | 1991-02-19 | 63 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Fiberoptic Sensor Technlogies, 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.
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.
- Fiberoptic Medical Products, Inc. (5 510(k)s)
- Fiberoptic Fabrications, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Fiberoptic Sensor Technlogies, Inc.?
FDA lists 11 510(k) clearances under the applicant name “Fiberoptic Sensor Technlogies, Inc.” (first 1987, latest 1995), 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 Fiberoptic Sensor Technlogies, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Fiberoptic Sensor Technlogies, Inc. is 96 days.
Which FDA product codes appear under Fiberoptic Sensor Technlogies, Inc.?
The most frequent FDA product codes under this applicant name are FEN (Device, Cystometric, Hydraulic, 8); DXO (Transducer, Pressure, Catheter Tip, 1); EXY (Uroflowmeter, 1).
Next steps
- See all 11 Fiberoptic Sensor Technlogies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FEN, Fiberoptic Sensor Technlogies, 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.