Cardiotronics, Inc.: FDA filings under this applicant name
FDA lists 27 510(k) clearances under the applicant name “Cardiotronics, Inc.” (first 1988, latest 1995), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 72 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 |
|---|---|---|---|
| LDD | Dc-Defibrillator, Low-Energy, (Including Paddles) | 14 | 14 |
| DRO | Pacemaker, Cardiac, External Transcutaneous (Non-Invasive) | 9 | 9 |
| DRX | Electrode, Electrocardiograph | 2 | 2 |
| DPS | Electrocardiograph | 1 | 1 |
| GXD | Generator, Lesion, Radiofrequency | 1 | 1 |
Review panels
- Cardiovascular (26)
- Neurology (1)
Most recent Cardiotronics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K932903 | EKG VEST | DRX | 1995-02-24 | 618 |
| K922064 | MODEL #510 STEALTH-PLATE DISPERSIVE ELECTRODE | GXD | 1992-12-01 | 211 |
| K923297 | MODEL #340 STEALTH-TRODE+LS | LDD | 1992-09-18 | 74 |
| K922227 | MODEL #225-ST SHOCK-TRODE ADULT DEFIB PADS STERILE | LDD | 1992-06-11 | 30 |
| K922173 | MODEL # 830 ST ADULT STIMULATION PADS (STERILE) | LDD | 1992-06-11 | 34 |
| K922172 | MODEL # 230 ST STEALTH-TRODE DEFIB PADS (STERILE) | LDD | 1992-06-11 | 34 |
| K921606 | MODEL #125 CHILD STIMULATION PADS | LDD | 1992-05-26 | 53 |
| K920086 | SHOCK-PATCH ADULT DEFIBRILLATION PADS | LDD | 1992-02-03 | 26 |
| K914725 | COORDINATOR, CABLE INPUT | DPS | 1991-11-05 | 15 |
| K912621 | MODEL #911 STEALTH MULTI PADS | LDD | 1991-10-16 | 125 |
17 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Cardiotronics, 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.
- Cardiotronics Systems, Inc. (4 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Cardiotronics, Inc.?
FDA lists 27 510(k) clearances under the applicant name “Cardiotronics, Inc.” (first 1988, latest 1995), across 5 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 Cardiotronics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cardiotronics, Inc. is 72 days.
Which FDA product codes appear under Cardiotronics, Inc.?
The most frequent FDA product codes under this applicant name are LDD (Dc-Defibrillator, Low-Energy, (Including Paddles), 14); DRO (Pacemaker, Cardiac, External Transcutaneous (Non-Invasive), 9); DRX (Electrode, Electrocardiograph, 2).
Next steps
- See all 27 Cardiotronics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LDD, Cardiotronics, 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 (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.