Card Guard Scientific Survival , Ltd.: FDA filings under this applicant name
FDA lists 49 510(k) clearances under the applicant name “Card Guard Scientific Survival , Ltd.” (first 1988, latest 2011), across 12 product codes in 4 review panels. Median 510(k) review time under this name: 74 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 |
|---|---|---|---|
| DXH | Transmitters And Receivers, Electrocardiograph, Telephone | 28 | 28 |
| DSI | Detector And Alarm, Arrhythmia | 5 | 5 |
| DSH | Recorder, Magnetic Tape, Medical | 3 | 3 |
| HGM | System, Monitoring, Perinatal | 3 | 3 |
| BZH | Meter, Peak Flow, Spirometry | 2 | 2 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 2 | 2 |
| CGA | Glucose Oxidase, Glucose | 1 | 1 |
| DQA | Oximeter | 1 | 1 |
| DXQ | Blood Pressure Cuff | 1 | 1 |
| HEL | Monitor, Heart Rate, Fetal, Ultrasonic | 1 | 1 |
Plus 2 more product codes.
Review panels
Most recent Card Guard Scientific Survival , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K111745 | KING OF HEARTS EXPRESS AF CARDIAC EVENT RECORDER | DSH | 2011-08-01 | 41 |
| K110499 | CG-5108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR | DSI | 2011-04-06 | 43 |
| K101703 | MODIFICATION TO: CG-6108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR, MODEL FG-00084 | DSI | 2010-07-13 | 26 |
| K101639 | CG-6108 ACT-IL CONTINUOUS ECG MONITOR AND ARRYTHMIA DETECTOR | DSI | 2010-06-25 | 15 |
| K083174 | HEALTHEPOD | DXH | 2009-12-17 | 416 |
| K082521 | EASY2CHECK BLOOD GLUCOSE AND BLOOD PRESSURE MONITORING SYSTEM | NBW | 2009-01-16 | 136 |
| K081257 | CG-6108 ACT-3L CONTINUOUS ECG MONITOR & ARRHYTHMIA DETECTOR | DSI | 2008-05-29 | 27 |
| K071995 | CG-6108 CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR | DSI | 2007-12-18 | 151 |
| K061428 | PMP4 APPLICATION | MSX | 2006-10-16 | 146 |
| K061528 | SELFCHECK GLUCO | CGA | 2006-09-22 | 112 |
39 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Card Guard Scientific Survival , Ltd..
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.
- Card Guard , Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Card Guard Scientific Survival , Ltd.?
FDA lists 49 510(k) clearances under the applicant name “Card Guard Scientific Survival , Ltd.” (first 1988, latest 2011), across 12 product codes in 4 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 Card Guard Scientific Survival , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Card Guard Scientific Survival , Ltd. is 74 days.
Which FDA product codes appear under Card Guard Scientific Survival , Ltd.?
The most frequent FDA product codes under this applicant name are DXH (Transmitters And Receivers, Electrocardiograph, Telephone, 28); DSI (Detector And Alarm, Arrhythmia, 5); DSH (Recorder, Magnetic Tape, Medical, 3).
Next steps
- See all 49 Card Guard Scientific Survival , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code DXH, Card Guard Scientific Survival , Ltd.'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.