Cleared Traditional

K921727 - CORE MONITORING SYSTEM-SP1475/6275/5607/5708/4575

K921727 is an FDA 510(k) clearance for CORE MONITORING SYSTEM-SP1475/6275/5607..., manufactured by Viggo-Spectramed. The device is a Class 2 Obstetrics & Gynecology device with product code KNF cleared through the Traditional 510(k) pathway after a 760-day FDA review.

K921727 · Viggo-Spectramed · Obstetrics & Gynecology device
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Optimized for regulatory review, auditing and printing
May 1994
Decision
760d
Days
Class 2
Risk

K921727 is an FDA 510(k) clearance for the CORE MONITORING SYSTEM-SP1475/6275/5607/5708/4575. Classified as Coagulator-cutter, Endoscopic, Unipolar (and Accessories) (product code KNF), Class II - Special Controls.

Submitted by Viggo-Spectramed (Oxnard, US). The FDA issued a Cleared decision on May 10, 1994 after a review of 760 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4160 - 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 Viggo-Spectramed devices

FDA 510(k) Submission Details - K921727

510(k) Number K921727 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 1992
Decision Date May 10, 1994
Days to Decision 760 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
600d slower than avg
Panel avg: 160d · This submission: 760d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNF Device Classification - Class 2, Special Controls

Product Code KNF Coagulator-cutter, Endoscopic, Unipolar (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.4160
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 - KNF Coagulator-cutter, Endoscopic, Unipolar (and Accessories)

All 35
Devices cleared under the same product code (KNF) and FDA review panel - the closest regulatory comparables to K921727.
KARL STORZ MONOPOLAR COAGULATION, NEEDLE, LOOP ELECTRODES
K944793 · KARL STORZ Endoscopy-America, Inc. · Jan 1995
KARL STORZ INSULATED SCISSORS
K944297 · KARL STORZ Endoscopy-America, Inc. · Dec 1994
KARL STORZ INSULATED BIOPSY FORCEPS
K944300 · KARL STORZ Endoscopy-America, Inc. · Dec 1994
ENDOMED LAPAROSCOPY INSTRUMENTS
K921686 · Buckman Co., Inc. · Mar 1994
REFLEX(R) ESC
K924200 · Richard-Allan Medical Ind., Inc. · Feb 1994
ELECTRO-GYNE ELECTROSURGICAL GENERATOR
K871960 · Cabot Medical Corp. · Jul 1987