Cleared Traditional

K960553 - CARD GUARD MODEL CG-900

K960553 is an FDA 510(k) clearance for CARD GUARD MODEL CG-900, manufactured by Card Guard Scientific Survival , Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code HGM cleared through the Traditional 510(k) pathway after a 439-day FDA review.

K960553 · Card Guard Scientific Survival , Ltd. · Obstetrics & Gynecology device
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Apr 1997
Decision
439d
Days
Class 2
Risk

K960553 is an FDA 510(k) clearance for the CARD GUARD MODEL CG-900. Classified as System, Monitoring, Perinatal (product code HGM), Class II - Special Controls.

Submitted by Card Guard Scientific Survival , Ltd. (Malibu, US). The FDA issued a Cleared decision on April 22, 1997 after a review of 439 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.2740 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Obstetrics & Gynecology submissions.

View all Card Guard Scientific Survival , Ltd. devices

FDA 510(k) Submission Details - K960553

510(k) Number K960553 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 1996
Decision Date April 22, 1997
Days to Decision 439 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
279d slower than avg
Panel avg: 160d · This submission: 439d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HGM Device Classification - Class 2, Special Controls

Product Code HGM System, Monitoring, Perinatal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.2740
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HGM System, Monitoring, Perinatal

All 99
Devices cleared under the same product code (HGM) and FDA review panel - the closest regulatory comparables to K960553.
WATCHCHILD OBSTERICAL PATIENT DATA MANAGEMENT SYSTEM
K974248 · Air-Shields, Inc. · Oct 1998
BIRTHNET II PERINATAL PATIENT DATA MANAGEMENT SYSTEM
K965008 · Spacelabs Medical, Inc. · Dec 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS5169
K971099 · Alexander Mfg. Co. · Jun 1997
COROMETRICS 120 SERIES MATERNAL/FETAL MONITOR
K964770 · Ge Medical Systems Information Technologies · Feb 1997
COROMETRICS FETAL MOVEMENT DETECTION KIT
K955559 · Ge Medical Systems Information Technologies · Mar 1996
FETALGARD 3000 - MODELS IP1, IP2, AP2 AND AP3
K950420 · Analogic Corp. · May 1995