Kay Elemetrics Corp.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Kay Elemetrics Corp.” (first 1992, latest 1999), across 4 product codes in 3 review panels. Median 510(k) review time under this name: 80 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 |
|---|---|---|---|
| EQL | Laryngostroboscope | 2 | 2 |
| KLA | Monitor, Esophageal Motility, Anorectal Motility, And Tube | 1 | 1 |
| KLX | Electroglottograph | 1 | 1 |
| LLZ | System, Image Processing, Radiological | 1 | 1 |
Review panels
Most recent Kay Elemetrics Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K991738 | DIGITAL VIDEO RECORDING SYSTEM | LLZ | 1999-08-13 | 84 |
| K990240 | ELECTROGLOTTOGRAPH | KLX | 1999-03-11 | 45 |
| K954798 | 7100 SWALLOWING WORKSTATION | KLA | 1996-06-04 | 230 |
| K921285 | 9105 RIGID TELESCOPIC ENDOSCOPE | EQL | 1992-05-28 | 72 |
| K921184 | RLS 9100 RHINO-LARYNGEAL STROBOSCOPE | EQL | 1992-05-28 | 80 |
Recalls
openFDA lists no recalls under a recalling firm named Kay Elemetrics 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 Kay Elemetrics Corp.?
FDA lists 5 510(k) clearances under the applicant name “Kay Elemetrics Corp.” (first 1992, latest 1999), across 4 product codes in 3 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 Kay Elemetrics Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Kay Elemetrics Corp. is 80 days.
Which FDA product codes appear under Kay Elemetrics Corp.?
The most frequent FDA product codes under this applicant name are EQL (Laryngostroboscope, 2); KLA (Monitor, Esophageal Motility, Anorectal Motility, And Tube, 1); KLX (Electroglottograph, 1).
Next steps
- See all 5 Kay Elemetrics Corp. clearances with predicates and recalls
- Run predicate analysis for product code EQL, Kay Elemetrics 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.