Transidyne General Corp.: FDA filings under this applicant name
FDA lists 21 510(k) clearances under the applicant name “Transidyne General Corp.” (first 1978, latest 1996), across 16 product codes in 6 review panels. Median 510(k) review time under this name: 42 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 |
|---|---|---|---|
| HGW | Sampler, Blood, Fetal | 3 | 3 |
| CHL | Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph | 2 | 2 |
| EGS | Handpiece, Contra- And Right-Angle Attachment, Dental | 2 | 2 |
| JQT | Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica | 2 | 2 |
| CBT | Arterial Blood Sampling Kit | 1 | 1 |
| FMF | Syringe, Piston | 1 | 1 |
| FRG | Wrap, Sterilization | 1 | 1 |
| FXX | Mask, Surgical | 1 | 1 |
| GFA | Blade, Saw, General & Plastic Surgery, Surgical | 1 | 1 |
| GFF | Bur, Surgical, General & Plastic Surgery | 1 | 1 |
Plus 6 more product codes.
Review panels
- Clinical Chemistry (6)
- General and Plastic Surgery (5)
- General Hospital (3)
- Obstetrics and Gynecology (3)
- Anesthesiology (2)
- Dental (2)
Most recent Transidyne General Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K961217 | BODILY FLUID DISPOSAL KIT | FXX | 1996-07-25 | 119 |
| K955658 | LACERATION TRAY | FRG | 1996-01-25 | 44 |
| K950773 | PROPHYLAXIS PACK | EGS | 1995-03-31 | 38 |
| K950743 | ORAL PROCEDURE PACK | EGS | 1995-03-31 | 42 |
| K950449 | SURGICAL BUR | GFF | 1995-03-01 | 26 |
| K950403 | SURGICAL SAW BLADES | GFA | 1995-02-21 | 21 |
| K924811 | I.V. START KIT | LRS | 1993-06-17 | 265 |
| K924243 | TRACHEOSTOMY CARE KIT | JOH | 1993-06-16 | 296 |
| K922339 | SUTURE REMOVAL KIT | MCZ | 1992-12-11 | 206 |
| K922041 | PRIMARY SURGICAL DRESSING TRAY | FMF | 1992-11-06 | 189 |
11 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Transidyne General 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Transidyne General Corp.?
FDA lists 21 510(k) clearances under the applicant name “Transidyne General Corp.” (first 1978, latest 1996), across 16 product codes in 6 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 Transidyne General Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Transidyne General Corp. is 42 days.
Which FDA product codes appear under Transidyne General Corp.?
The most frequent FDA product codes under this applicant name are HGW (Sampler, Blood, Fetal, 3); CHL (Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph, 2); EGS (Handpiece, Contra- And Right-Angle Attachment, Dental, 2).
Next steps
- See all 21 Transidyne General Corp. clearances with predicates and recalls
- Run predicate analysis for product code HGW, Transidyne General 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.