Instruments For Cardiac Research: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Instruments For Cardiac Research” (first 1977, latest 1984), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 38 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 |
|---|---|---|---|
| DSI | Detector And Alarm, Arrhythmia | 4 | 4 |
| DPS | Electrocardiograph | 1 | 1 |
| DQK | Computer, Diagnostic, Programmable | 1 | 1 |
| DSF | Recorder, Paper Chart | 1 | 1 |
| DSH | Recorder, Magnetic Tape, Medical | 1 | 1 |
Review panels
- Cardiovascular (8)
Most recent Instruments For Cardiac Research 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K834397 | HOLTER CARDIOGRAPHY SYS 6201 | DSI | 1984-04-17 | 125 |
| K821173 | EVENTMASTER 3 HOLTER EVENT SCANNER | DSF | 1982-05-18 | 22 |
| K820856 | EVENTMASTER 2 | DSI | 1982-04-29 | 31 |
| K820011 | CARDIOSTRESS | DPS | 1982-01-22 | 17 |
| K812920 | EVENT MASTER | DSH | 1981-12-02 | 44 |
| K801903 | SERIES 4000 STRESS & EXERCISE SYSTEM | DSI | 1981-03-11 | 212 |
| K771374 | SCANNER TREND SYSTEM | DSI | 1977-08-04 | 10 |
| K770705 | CARDIAC ACQUISITION SYSTEM, ICR 2001 | DQK | 1977-06-02 | 45 |
Recalls
openFDA lists no recalls under a recalling firm named Instruments For Cardiac Research.
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.
- Instruments For Medicine and Diagnostics (2 510(k)s)
- Instruments Medicaux G.B., Inc. (2 510(k)s)
- Instruments of Sweden, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Instruments For Cardiac Research?
FDA lists 8 510(k) clearances under the applicant name “Instruments For Cardiac Research” (first 1977, latest 1984), across 5 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Instruments For Cardiac Research?
The median time from FDA receipt to decision across 510(k)s cleared under the name Instruments For Cardiac Research is 38 days.
Which FDA product codes appear under Instruments For Cardiac Research?
The most frequent FDA product codes under this applicant name are DSI (Detector And Alarm, Arrhythmia, 4); DPS (Electrocardiograph, 1); DQK (Computer, Diagnostic, Programmable, 1).
Next steps
- See all 8 Instruments For Cardiac Research clearances with predicates and recalls
- Run predicate analysis for product code DSI, Instruments For Cardiac Research'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.