Sheathing Technologies, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Sheathing Technologies, Inc.” (first 1999, latest 2016), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 101 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 | 1 | 268 |
| 2013 | 1 | 29 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 120 |
| 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 |
|---|---|---|---|
| ITX | Transducer, Ultrasonic, Diagnostic | 4 | 4 |
| MUI | Media, Coupling, Ultrasound | 2 | 2 |
| FDF | Colonoscope And Accessories, Flexible/Rigid | 1 | 1 |
Review panels
Most recent Sheathing Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K153212 | Sheathes Ultrasound Probe Covers | ITX | 2016-03-04 | 120 |
| K130041 | SHEATHES STERILE ULTRASOUND GEL | MUI | 2013-02-06 | 29 |
| K112827 | SHEATHES ULTRASOND GEL | MUI | 2012-06-22 | 268 |
| K100966 | COLONOSCOPE/SIGMOIDOSCOPE SHEATHES | FDF | 2010-08-03 | 117 |
| K091828 | SHEATHESISO ULTRASOUND TRANSDUCER COVER | ITX | 2009-09-28 | 101 |
| K043425 | SHEATHES NEEDLE GUIDE, MODEL NG-SR-A-484-KIT (THERE WILL BE VARIOUS MODEL NUMBERS BASED ON TRANSDUCER AND COVER) | ITX | 2005-02-28 | 77 |
| K990175 | SHEATHES (NON-LATEX), STERILE | ITX | 1999-04-21 | 92 |
Recalls
1 product recalls in 1 recall events; 1 initiated in the last five years. Most recent: 2025-11-17.
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 Sheathing Technologies, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Sheathing Technologies, Inc.” (first 1999, latest 2016), 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 Sheathing Technologies, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sheathing Technologies, Inc. is 101 days.
Which FDA product codes appear under Sheathing Technologies, Inc.?
The most frequent FDA product codes under this applicant name are ITX (Transducer, Ultrasonic, Diagnostic, 4); MUI (Media, Coupling, Ultrasound, 2); FDF (Colonoscope And Accessories, Flexible/Rigid, 1).
Next steps
- See all 7 Sheathing Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code ITX, Sheathing Technologies, 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.