Kaycor Intl., Ltd.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Kaycor Intl., Ltd.” (first 1981, latest 1997), across 6 product codes in 2 review panels. Median 510(k) review time under this name: 43 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 |
|---|---|---|---|
| EKX | Handpiece, Direct Drive, Ac-Powered | 2 | 2 |
| EAP | Unit, X-Ray, Intraoral | 1 | 1 |
| EGY | Processor, Radiographic-Film, Automatic, Dental | 1 | 1 |
| EHD | Unit, X-Ray, Extraoral With Timer | 1 | 1 |
| KLC | Chair, Dental, With Operative Unit | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent Kaycor Intl., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K965072 | PANOURA ULTRA PAN AND PANOURA ULTRA PAN/CEPH PANORAMIC/CEPHALOMETRIC X-RAY UNIT | EHD | 1997-01-27 | 39 |
| K931717 | YOSHIDA/KAYCOR X-707 WALL MOUNTED DENTAL X-RAY | EAP | 1993-09-20 | 167 |
| K832063 | ROBIN CORDLESS HANDPIECE | EKX | 1983-08-26 | 60 |
| K822740 | K30000 DENTAL CHAIR | KLC | 1982-09-28 | 19 |
| K813348 | YOSHIDA RIDO-F, MODEL LM-01 | EKX | 1982-01-07 | 41 |
| K811210 | YOSHIDA-PANOURA 10 | — | 1981-08-24 | 112 |
| K811211 | YOSHIDA AP 100 | EGY | 1981-06-16 | 43 |
Recalls
openFDA lists no recalls under a recalling firm named Kaycor Intl., Ltd..
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 Kaycor Intl., Ltd.?
FDA lists 7 510(k) clearances under the applicant name “Kaycor Intl., Ltd.” (first 1981, latest 1997), across 6 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 Kaycor Intl., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Kaycor Intl., Ltd. is 43 days.
Which FDA product codes appear under Kaycor Intl., Ltd.?
The most frequent FDA product codes under this applicant name are EKX (Handpiece, Direct Drive, Ac-Powered, 2); EAP (Unit, X-Ray, Intraoral, 1); EGY (Processor, Radiographic-Film, Automatic, Dental, 1).
Next steps
- See all 7 Kaycor Intl., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code EKX, Kaycor Intl., Ltd.'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.