Cleared Traditional

K003876 - US SENSOR #CG-930P

Also marketed or referenced as:
TOCO SENSOR CG-940P

K003876 is an FDA 510(k) clearance for US SENSOR #CG-930P, manufactured by Card Guard Scientific Survival , Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code HEL cleared through the Traditional 510(k) pathway after a 206-day FDA review.

K003876 · Card Guard Scientific Survival , Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2001
Decision
206d
Days
Class 2
Risk

K003876 is an FDA 510(k) clearance for the US SENSOR #CG-930P. Classified as Monitor, Heart Rate, Fetal, Ultrasonic (product code HEL), Class II - Special Controls.

Submitted by Card Guard Scientific Survival , Ltd. (Rehovot, IL). The FDA issued a Cleared decision on July 9, 2001 after a review of 206 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.2660 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Card Guard Scientific Survival , Ltd. devices

FDA 510(k) Submission Details - K003876

510(k) Number K003876 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 2000
Decision Date July 09, 2001
Days to Decision 206 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
45d slower than avg
Panel avg: 161d · This submission: 206d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HEL Device Classification - Class 2, Special Controls

Product Code HEL Monitor, Heart Rate, Fetal, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.2660
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 - HEL Monitor, Heart Rate, Fetal, Ultrasonic

Devices cleared under the same product code (HEL) and FDA review panel - the closest regulatory comparables to K003876.
TRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETER MONITORING
K010920 · Medical Cables, Inc. · Jun 2001
COROMETRICS MODEL 5700 AND 2264 WATERTIGHT TRANSDUCER
K982651 · Corometrics Medical Systems, Inc. · Dec 1998
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M006
K971240 · Alexander Mfg. Co. · Jun 1997