Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Card Guard Scientific Survival , Ltd. — Predicate Candidate Screening
49 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
74 daysmedian FDA review time
439 days90th percentile
49clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K111745 | KING OF HEARTS EXPRESS AF CARDIAC EVENT RECORDER | Card Guard Scientific Survival , Ltd. | 2011-08-01 | 41 | 0 |
| K110499 | CG-5108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTO | Card Guard Scientific Survival , Ltd. | 2011-04-06 | 43 | 2 |
| K101703 | MODIFICATION TO: CG-6108 ACT-3L CONTINUOUS ECG MONITOR AND A | Card Guard Scientific Survival , Ltd. | 2010-07-13 | 26 | 0 |
| K101639 | CG-6108 ACT-IL CONTINUOUS ECG MONITOR AND ARRYTHMIA DETECTOR | Card Guard Scientific Survival , Ltd. | 2010-06-25 | 15 | 2 |
| K083174 | HEALTHEPOD | Card Guard Scientific Survival , Ltd. | 2009-12-17 | 416 | 0 |
| K082521 | EASY2CHECK BLOOD GLUCOSE AND BLOOD PRESSURE MONITORING SYSTE | Card Guard Scientific Survival , Ltd. | 2009-01-16 | 136 | 0 |
| K081257 | CG-6108 ACT-3L CONTINUOUS ECG MONITOR & ARRHYTHMIA DETECTOR | Card Guard Scientific Survival , Ltd. | 2008-05-29 | 27 | 2 |
| K071995 | CG-6108 CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR | Card Guard Scientific Survival , Ltd. | 2007-12-18 | 151 | 2 |
| K061428 | PMP4 APPLICATION | Card Guard Scientific Survival , Ltd. | 2006-10-16 | 146 | 0 |
| K061528 | SELFCHECK GLUCO | Card Guard Scientific Survival , Ltd. | 2006-09-22 | 112 | 0 |
| K060911 | CG-6108 ARRHYTHMIA ECG EVENT RECORDER | Card Guard Scientific Survival , Ltd. | 2006-08-22 | 141 | 0 |
| K060703 | PMP4 BP PRO BLOOD PRESSURE MONITOR | Card Guard Scientific Survival , Ltd. | 2006-04-04 | 19 | 0 |
| K052556 | CG-7000DX-BT ECG RECORDER/TRANSMITTER | Card Guard Scientific Survival , Ltd. | 2006-01-09 | 115 | 0 |
| K053395 | BP PRO BLOOD PRESSURE MONITOR | Card Guard Scientific Survival , Ltd. | 2005-12-23 | 17 | 0 |
| K050940 | PMP4 MEDICAL WEB CENTER | Card Guard Scientific Survival , Ltd. | 2005-07-01 | 78 | 0 |
| K050853 | PMP4 SPIROPRO | Card Guard Scientific Survival , Ltd. | 2005-05-04 | 30 | 0 |
| K042254 | PMP4 SELFCHECK ECG | Card Guard Scientific Survival , Ltd. | 2005-01-13 | 146 | 0 |
| K043162 | PMP4 OXY PRO | Card Guard Scientific Survival , Ltd. | 2004-12-29 | 43 | 0 |
| K023689 | CG-500 PMP PERSONAL MEDICAL PHONE SYSTEM | Card Guard Scientific Survival , Ltd. | 2003-01-17 | 77 | 0 |
| K023356 | KLOCK WATCH STYLE DIGITAL BLOOD PRESSURE MONITOR | Card Guard Scientific Survival , Ltd. | 2003-01-16 | 101 | 0 |
| K024365 | TM2005 PERSONAL MEDICAL PHONE CENTER | Card Guard Scientific Survival , Ltd. | 2003-01-15 | 15 | 0 |
| K021574 | TM2000 FETALTRACE TRANSTELEPHONIC RECEIVING CENTER | Card Guard Scientific Survival , Ltd. | 2002-08-12 | 90 | 0 |
| K020825 | KING OF HEARTS EXPRESS + AF MONITOR | Card Guard Scientific Survival , Ltd. | 2002-04-05 | 22 | 0 |
| K013879 | TM2000, MODEL 1 | Card Guard Scientific Survival , Ltd. | 2002-02-01 | 70 | 0 |
| K013175 | TM2000 EASYTRACE PLUS RECEIVING CENTER | Card Guard Scientific Survival , Ltd. | 2001-10-30 | 36 | 0 |
| K012223 | CG-2211 SELFCHECK ECG TRANSMITTER | Card Guard Scientific Survival , Ltd. | 2001-09-10 | 56 | 0 |
| K012187 | CG-3250 MINIRECEIVER | Card Guard Scientific Survival , Ltd. | 2001-08-14 | 33 | 0 |
| K003876 | US SENSOR #CG-930P; TOCO SENSOR CG-940P | Card Guard Scientific Survival , Ltd. | 2001-07-09 | 206 | 0 |
| K010552 | CG-900P FETAL/MATERNAL MONITOR | Card Guard Scientific Survival , Ltd. | 2001-05-11 | 74 | 0 |
| K003220 | PERSONAL ECG TRANSMITTER, MODEL CG-6550 | Card Guard Scientific Survival , Ltd. | 2000-11-08 | 23 | 0 |
| K000225 | CARD GUARD PERSONAL ELECTROCARDIOGRAM TRANSMITTER, MODEL CG- | Card Guard Scientific Survival , Ltd. | 2000-02-11 | 18 | 0 |
| K994009 | CG-2100 ECG TRANSMITTER | Card Guard Scientific Survival , Ltd. | 1999-12-21 | 25 | 0 |
| K993799 | CG-7000DX ECG RECORDER/TRANSMITTER | Card Guard Scientific Survival , Ltd. | 1999-12-10 | 31 | 0 |
| K992696 | ECG MINIMONITOR, MODEL CG-5000 | Card Guard Scientific Survival , Ltd. | 1999-10-07 | 56 | 0 |
| K990478 | CARD GUARD, MODEL CG-6550 | Card Guard Scientific Survival , Ltd. | 1999-08-31 | 196 | 0 |
| K992164 | TELEMEDICINE 2000 | Card Guard Scientific Survival , Ltd. | 1999-08-30 | 66 | 0 |
| K991307 | TELEMEDICINE 2000 | Card Guard Scientific Survival , Ltd. | 1999-06-14 | 59 | 0 |
| K983026 | PACEMAKER DATA PMD TRANSMITTER, MODEL CG-4000 | Card Guard Scientific Survival , Ltd. | 1998-12-02 | 93 | 0 |
| K964836 | CARD GUARD, MODEL CG-7100 | Card Guard Scientific Survival , Ltd. | 1997-07-28 | 241 | 0 |
| K960553 | CARD GUARD MODEL CG-900 | Card Guard Scientific Survival , Ltd. | 1997-04-22 | 439 | 0 |
| K963811 | CARD GUARD MODEL CG-6106 PERSONAL ELECTROCARDIOGRAM (ECG) TR | Card Guard Scientific Survival , Ltd. | 1996-12-04 | 72 | 0 |
| K954350 | CARD GUARD MODEL CG-6500 | Card Guard Scientific Survival , Ltd. | 1996-09-10 | 358 | 0 |
| K935909 | CG-1000 PERSONAL ECG TRANSMITTER | Card Guard Scientific Survival , Ltd. | 1995-04-28 | 505 | 0 |
| K934795 | CARD GUARD | Card Guard Scientific Survival , Ltd. | 1995-04-14 | 555 | 0 |
| K942704 | CARD GUARD, MODEL CG-7000D ECG RECORDER/TRANSMITTER | Card Guard Scientific Survival , Ltd. | 1994-12-05 | 180 | 0 |
| K924486 | CARD GUARD, MODEL CG-9000 | Card Guard Scientific Survival , Ltd. | 1994-10-31 | 788 | 0 |
| K926515 | CARD GUARD MODEL CG-8000 | Card Guard Scientific Survival , Ltd. | 1994-03-30 | 455 | 0 |
| K910884 | CARD GUARD, MODELS CG-6000 & CG-7000 | Card Guard Scientific Survival , Ltd. | 1991-10-16 | 226 | 0 |
| K882290 | CARD GUARD, MODEL CG-2000 | Card Guard Scientific Survival , Ltd. | 1988-07-22 | 51 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda