510(k) Report

FDA applicant

Card Guard Scientific Survival, Ltd.

Rehovot, IL49 decisions1988–20113 recalls

FDA records 49 decisions for Card Guard Scientific Survival, Ltd. (Rehovot, IL) from 1988 to 2011: 49 510(k) clearances. Most are in product codes DXH (Transmitters And Receivers…) and DSI (Detector And Alarm, Arrhythmia). Its devices cite 37 predicates, 27 of them its own earlier devices. 3 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Card Guard Scientific Survival, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2011

2007: 12008: 12009: 22010: 22011: 2
2007high 2 (2009) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

3in 2011

2011: 3
2007high 3 (2011) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Card Guard Scientific Survival, Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Card Guard Scientific Survival, Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Other applicant names beginning “Card”

FDA records each applicant name separately; these may or may not be the same firm.