Kontron Instruments, Inc.: FDA filings under this applicant name
FDA lists 58 510(k) clearances under the applicant name “Kontron Instruments, Inc.” (first 1981, latest 1997), across 27 product codes in 7 review panels. Median 510(k) review time under this name: 156 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 |
|---|---|---|---|
| DSP | System, Balloon, Intra-Aortic And Control | 17 | 17 |
| DPS | Electrocardiograph | 5 | 5 |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 5 | 5 |
| DQA | Oximeter | 3 | 3 |
| DSI | Detector And Alarm, Arrhythmia | 2 | 2 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 2 | 2 |
| HGL | Transducer, Ultrasonic, Obstetric | 2 | 2 |
| HGM | System, Monitoring, Perinatal | 2 | 2 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 2 | 2 |
| BZQ | Monitor, Breathing Frequency | 1 | 1 |
Plus 17 more product codes.
Review panels
- Cardiovascular (38)
- Anesthesiology (7)
- Obstetrics and Gynecology (5)
- Radiology (4)
- Neurology (2)
- Gastroenterology and Urology (1)
- General Hospital (1)
Most recent Kontron Instruments, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K971038 | KONTRON KOLORMON PLUS ECG WITH RESPIRATION MODULE | DPS | 1997-09-24 | 188 |
| K932268 | MODIFICATIONS TO INTRA-AORTIC BALLOONS | DSP | 1993-12-15 | 259 |
| K925248 | MODIFICATION OF INTRA-AORTIC BALLOON CATHETERS | DSP | 1993-09-27 | 346 |
| K923603 | INTRA-AORTIC BALLOON PUMP CATHETER - MODIFICATION | DYB | 1993-03-08 | 249 |
| K905313 | KONTRON INTRA-AORTIC BALLOON PUMP, MODEL KAAT II | DSP | 1991-06-19 | 203 |
| K903344 | 9.5 FR PERCUTANEOUS DB LUMEN 40CC FLEXI-CATH (TM) | DSP | 1991-01-15 | 174 |
| K896437 | KONTRON SIGMA 44 HVCD ULTRASOUND IMAGING SYSTEM | DPT | 1990-12-03 | 389 |
| K892222 | 9.5F PERCU DOUBLE LUMEN INTRA-AORTIC BALLOON | DSP | 1990-09-14 | 529 |
| K882955 | SUPERMON NEONATAL NON-INVASIVE BLOOD PRESS. 7283 | DXN | 1990-01-26 | 561 |
| K896386 | MINIMON 7133B PATIENT MONITOR | DPS | 1989-12-13 | 37 |
48 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Kontron 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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Kontron Medical Systems Sas (4 510(k)s)
- Kontron Electronics (3 510(k)s)
- Kontron, Inc. (1 510(k)s)
- Kontron Elektronik GmbH (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Kontron Instruments, Inc.?
FDA lists 58 510(k) clearances under the applicant name “Kontron Instruments, Inc.” (first 1981, latest 1997), across 27 product codes in 7 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 Kontron Instruments, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Kontron Instruments, Inc. is 156 days.
Which FDA product codes appear under Kontron Instruments, Inc.?
The most frequent FDA product codes under this applicant name are DSP (System, Balloon, Intra-Aortic And Control, 17); DPS (Electrocardiograph, 5); DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm), 5).
Next steps
- See all 58 Kontron Instruments, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DSP, Kontron 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.