Kone Instruments, Inc.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Kone Instruments, Inc.” (first 1982, latest 1987), 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 |
|---|---|---|---|
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 5 | 5 |
| JJF | Analyzer, Chemistry, Micro, For Clinical Use | 3 | 3 |
| DRX | Electrode, Electrocardiograph | 1 | 1 |
| DSI | Detector And Alarm, Arrhythmia | 1 | 1 |
| JFP | Electrode, Ion Specific, Calcium | 1 | 1 |
| LDD | Dc-Defibrillator, Low-Energy, (Including Paddles) | 1 | 1 |
Review panels
- Cardiovascular (8)
- Clinical Chemistry (4)
Most recent Kone Instruments, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K873345 | 'MICROLYTE 4/5' | JFP | 1987-09-11 | 23 |
| K870777 | PROGRESS PLUS SELECTIVE CHEMISTRY ANALYZER | JJF | 1987-03-13 | 15 |
| K863466 | M700 STRESS MONITOR | DRT | 1986-12-22 | 105 |
| K862655 | SIGNA II RESTING ECG ELECTRODE | DRX | 1986-08-06 | 23 |
| K860767 | MODEL E 600 ELECTROCARDIOGRAPH | DSI | 1986-04-23 | 51 |
| K853354 | MEDIC 4 | LDD | 1985-10-11 | 60 |
| K840200 | PROGRESS SELECTIVE DHEMISTRY ANALYZ | JJF | 1984-04-04 | 76 |
| K830433 | PATIENT MONITOR 575 | DRT | 1983-03-24 | 43 |
| K830432 | CENTRAL STATION 590 | DRT | 1983-03-24 | 43 |
| K822952 | 560 | DRT | 1982-11-01 | 28 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Kone Instruments, 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 Kone Instruments, Inc.?
FDA lists 12 510(k) clearances under the applicant name “Kone Instruments, Inc.” (first 1982, latest 1987), 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 Kone Instruments, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Kone Instruments, Inc. is 43 days.
Which FDA product codes appear under Kone Instruments, Inc.?
The most frequent FDA product codes under this applicant name are DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm), 5); JJF (Analyzer, Chemistry, Micro, For Clinical Use, 3); DRX (Electrode, Electrocardiograph, 1).
Next steps
- See all 12 Kone Instruments, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DRT, Kone Instruments, 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.