Cleared Traditional

K960553 - CARD GUARD MODEL CG-900 (FDA 510(k) Clearance)

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K960553 · Card Guard Scientific Survival , Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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
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.

Device Classification

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 213
Devices cleared under the same product code (HGM) and FDA review panel - the closest regulatory comparables to K960553.
ANNE Maternal
K253021 · Sibel Health, Inc. · Feb 2026
Sonicaid Team3
K250777 · Huntleigh Healthcare , Ltd. · Sep 2025
Fetal & Maternal Monitor (F15A, F15A Air)
K241882 · Edan Instruments, Inc. · Aug 2025
Sonicaid Team3
K241368 · Huntleigh Healthcare , Ltd. · Feb 2025
PeriCALM Patterns 3.0
K241009 · Perigen, Inc. · Jan 2025
Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal (F&M) Patch (989803196341)
K233440 · Philips Medizin Systeme Boeblingen GmbH · Jul 2024