Cleared Traditional

K903992 - CYGNET CENTRAL

K903992 is an FDA 510(k) clearance for CYGNET CENTRAL, manufactured by Cygnet Co., Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HGM cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K903992 · Cygnet Co., Inc. · Obstetrics & Gynecology device
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Dec 1990
Decision
112d
Days
Class 2
Risk

K903992 is an FDA 510(k) clearance for the CYGNET CENTRAL. Classified as System, Monitoring, Perinatal (product code HGM), Class II - Special Controls.

Submitted by Cygnet Co., Inc. (San Jose, US). The FDA issued a Cleared decision on December 19, 1990 after a review of 112 days - within the typical 510(k) review window.

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: 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 Cygnet Co., Inc. devices

FDA 510(k) Submission Details - K903992

510(k) Number K903992 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 1990
Decision Date December 19, 1990
Days to Decision 112 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 160d · This submission: 112d
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 160
Devices cleared under the same product code (HGM) and FDA review panel - the closest regulatory comparables to K903992.
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