Ketronic, Inc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Ketronic, Inc.” (first 1984, latest 1985), across 7 product codes in 2 review panels. Median 510(k) review time under this name: 100 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 |
|---|---|---|---|
| BXB | Exerciser, Powered | 1 | 1 |
| ILK | Transport, Patient, Powered | 1 | 1 |
| INO | Chair, Positioning, Electric | 1 | 1 |
| ISD | Exerciser, Measuring | 1 | 1 |
| ITI | Wheelchair, Powered | 1 | 1 |
| IYX | Camera, Scintillation (Gamma) | 1 | 1 |
Plus 1 more product codes.
Review panels
- Physical Medicine (5)
- Radiology (1)
Most recent Ketronic, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K850877 | MONOLIFT MPE2, PLATFORM, CHAIR, FULLY FUTO PLATFOR | ILK | 1985-06-12 | 103 |
| K850873 | HILO TABLES, TYPE CH-4, CH-8, FW-6, FW-5, FW-2, AL | INO | 1985-06-12 | 103 |
| K850870 | MEDIFETTE ERGOMETER | — | 1985-06-12 | 103 |
| K850869 | MFE COUCH ERGOMETER | ISD | 1985-06-12 | 103 |
| K850868 | MFE CARDIAC STRESS SYSTEM | — | 1985-06-12 | 103 |
| K850872 | PHYACTION 300, 360, 370, 390 & 391 ELEC-MUSCLE-STI | — | 1985-06-06 | 97 |
| K850871 | TREDBAND TYPE I, IT, II & III - TREADMILLS | BXB | 1985-06-05 | 96 |
| K850876 | LIGTVOET L80.2 LIGHTFOOT L80.2 POWER WHEELCHAIR | ITI | 1985-05-16 | 76 |
| K850875 | ACTION-WHEELS & PLAY WHEELS | — | 1985-05-16 | 76 |
| K843288 | KETRONIC MEDAX - N | IYX | 1984-11-08 | 79 |
Recalls
openFDA lists no recalls under a recalling firm named Ketronic, Inc..
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 Ketronic, Inc.?
FDA lists 10 510(k) clearances under the applicant name “Ketronic, Inc.” (first 1984, latest 1985), across 7 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 Ketronic, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ketronic, Inc. is 100 days.
Which FDA product codes appear under Ketronic, Inc.?
The most frequent FDA product codes under this applicant name are BXB (Exerciser, Powered, 1); ILK (Transport, Patient, Powered, 1); INO (Chair, Positioning, Electric, 1).
Next steps
- See all 10 Ketronic, Inc. clearances with predicates and recalls
- Run predicate analysis for product code BXB, Ketronic, Inc.'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.