Kt Medical, Inc.: FDA clearances and approvals
Kt Medical, Inc. has 13 FDA 510(k) clearances (first 1980, latest 1980), across 6 product codes in 3 review panels. Median 510(k) review time: 28 days.
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 |
|---|---|---|---|
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 6 | 6 |
| JAF | Monitor, Ultrasonic, Nonfetal | 2 | 2 |
| KNG | Monitor, Ultrasonic, Fetal | 2 | 2 |
| DQK | Computer, Diagnostic, Programmable | 1 | 1 |
| DXK | Echocardiograph | 1 | 1 |
Plus 1 more product codes.
Review panels
- Radiology (8)
- Cardiovascular (2)
- Obstetrics and Gynecology (2)
Most recent Kt Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K800653 | SINVISION LINEAR ARRAY REAL TIME | DXK | 1980-07-21 | 119 |
| K800652 | MODEL E03 ECHO-OPTHALMOSCOPE | IYO | 1980-05-14 | 51 |
| K800101 | 4200 ME ECHOENCEPHALOGRAPH | IYO | 1980-05-02 | 109 |
| K800092 | COMBISON COMPUTER | DQK | 1980-04-08 | 85 |
| K800100 | 7200 MA ECHO-OPHTHALMOSCOPE | IYO | 1980-02-21 | 38 |
| K800099 | INTRACULA II | IYO | 1980-02-21 | 38 |
| K800098 | MINIFETON 200 | KNG | 1980-02-11 | 28 |
| K800097 | MINIVASON 9 | JAF | 1980-02-11 | 28 |
| K800096 | AMBIVASON DR-200 | JAF | 1980-02-11 | 28 |
| K800095 | MGD-3 | KNG | 1980-02-11 | 28 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Kt Medical, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Kt Medical, Inc. have?
Kt Medical, Inc. has 13 FDA 510(k) clearances (first 1980, latest 1980), across 6 product codes in 3 review panels.
How long does FDA take to clear Kt Medical, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Kt Medical, Inc.'s cleared 510(k)s is 28 days.
What devices does Kt Medical, Inc. make?
Its most frequent FDA product codes are IYO (System, Imaging, Pulsed Echo, Ultrasonic, 6); JAF (Monitor, Ultrasonic, Nonfetal, 2); KNG (Monitor, Ultrasonic, Fetal, 2).
Has Kt Medical, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Kt Medical, Inc. Related entities may recall under other names.
Next steps
- See all 13 Kt Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code IYO, Kt Medical, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.