Trylon Corp.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Trylon Corp.” (first 1995, latest 2004), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 148 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 |
|---|---|---|---|
| EAZ | Light, Operating, Dental | 2 | 2 |
| MPU | Source, Chemiluminescent Light | 2 | 2 |
| HET | Laparoscope, Gynecologic (And Accessories) | 1 | 1 |
| HFB | Forceps, Biopsy, Gynecological | 1 | 1 |
| HIC | Speculum, Vaginal, Nonmetal, Fiberoptic | 1 | 1 |
Review panels
- Obstetrics and Gynecology (5)
- Dental (2)
Most recent Trylon Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K033033 | VIZILITE-BLUE ORAL EXAM KIT | EAZ | 2004-11-22 | 423 |
| K011488 | SPIRABRUSH CX BIOPSY INSTRUMENT | HFB | 2002-02-22 | 283 |
| K012070 | ORALLITE COMPREHENSIVE EXAM TRAY | MPU | 2001-11-27 | 148 |
| K003995 | SPECULITE/ORALLITE | EAZ | 2001-03-16 | 80 |
| K963391 | SPECULITE | MPU | 1997-12-12 | 471 |
| K955790 | PAP PLUS SPECULOSCOPY COMPREHENSIVE PELVIC EXAM TRAY | HIC | 1996-03-21 | 90 |
| K953364 | SPECULITE | HET | 1995-12-08 | 144 |
Recalls
openFDA lists no recalls under a recalling firm named Trylon Corp..
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.
- Trylon Associates, Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Trylon Corp.?
FDA lists 7 510(k) clearances under the applicant name “Trylon Corp.” (first 1995, latest 2004), across 5 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 Trylon Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Trylon Corp. is 148 days.
Which FDA product codes appear under Trylon Corp.?
The most frequent FDA product codes under this applicant name are EAZ (Light, Operating, Dental, 2); MPU (Source, Chemiluminescent Light, 2); HET (Laparoscope, Gynecologic (And Accessories), 1).
Next steps
- See all 7 Trylon Corp. clearances with predicates and recalls
- Run predicate analysis for product code EAZ, Trylon Corp.'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.