Applied Cardiac Systems: FDA filings under this applicant name
FDA lists 5 510(k) clearances under 2 spellings of the applicant name “Applied Cardiac Systems” (first 1982, latest 2011), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 46 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 |
|---|---|---|---|
| DSH | Recorder, Magnetic Tape, Medical | 2 | 2 |
| DPS | Electrocardiograph | 1 | 1 |
| DRN | Device, Counter-Pulsating, External | 1 | 1 |
| QYX | Outpatient Cardiac Telemetry | 1 | 1 |
Review panels
- Cardiovascular (5)
Most recent Applied Cardiac Systems 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K103706 | THE CORE (CARDIAC OUTPATIENT REALTIME ECG) MONITOR | QYX | 2011-08-24 | 247 |
| K042413 | ACS MODEL NCP-2 | DRN | 2004-12-09 | 93 |
| K860249 | THE HOLTER REPORTER (TM) | DPS | 1986-03-11 | 46 |
| K833823 | HOLTER PERFORMER FEATHER WEIGHT/CASS | DSH | 1983-12-01 | 29 |
| K813602 | HOLTER PERFORMER | DSH | 1982-01-29 | 32 |
Recalls
openFDA lists no recalls under a recalling firm named Applied Cardiac Systems.
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.
FDA spellings included
FDA records this applicant under 2 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- Applied Cardiac Systems (4)
- Applied Cardiac Systems, Inc. (1)
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.
- Applied Medical Resources (115 510(k)s)
- Applied Medical Technology, Inc. (25 510(k)s)
- Applied Medical Technologies (24 510(k)s)
- Applied Medical Research (22 510(k)s)
- Applied Vascular Devices, Inc. (21 510(k)s)
- Applied Osteo Systems, Inc. (15 510(k)s)
- Applied Medical (14 510(k)s)
- Applied Urology, Inc. (13 510(k)s)
- Applied Medical Devices, Inc. (11 510(k)s)
- Applied Laboratories, Inc. (9 510(k)s)
- Applied Biomaterial Technologies (7 510(k)s)
- Applied Imaging Corp. (7 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Applied Cardiac Systems?
FDA lists 5 510(k) clearances under 2 spellings of the applicant name “Applied Cardiac Systems” (first 1982, latest 2011), across 4 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 Applied Cardiac Systems?
The median time from FDA receipt to decision across 510(k)s cleared under the name Applied Cardiac Systems is 46 days.
Which FDA product codes appear under Applied Cardiac Systems?
The most frequent FDA product codes under this applicant name are DSH (Recorder, Magnetic Tape, Medical, 2); DPS (Electrocardiograph, 1); DRN (Device, Counter-Pulsating, External, 1).
Next steps
- See all 5 Applied Cardiac Systems clearances with predicates and recalls
- Run predicate analysis for product code DSH, Applied Cardiac Systems'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.