Cleared Traditional

K954775 - FLO-STAT FLUID MONITORING SYSTEM

K954775 is an FDA 510(k) clearance for FLO-STAT FLUID MONITORING SYSTEM, manufactured by Gynecare Innovation Center. The device is a Class 2 Obstetrics & Gynecology device with product code HET cleared through the Traditional 510(k) pathway after a 206-day FDA review.

K954775 · Gynecare Innovation Center · Obstetrics & Gynecology device
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May 1996
Decision
206d
Days
Class 2
Risk

K954775 is an FDA 510(k) clearance for the FLO-STAT FLUID MONITORING SYSTEM. Classified as Laparoscope, Gynecologic (and Accessories) (product code HET), Class II - Special Controls.

Submitted by Gynecare Innovation Center (Sunnyvale, US). The FDA issued a Cleared decision on May 10, 1996 after a review of 206 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1720 - 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 Gynecare Innovation Center devices

FDA 510(k) Submission Details - K954775

510(k) Number K954775 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 1995
Decision Date May 10, 1996
Days to Decision 206 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
46d slower than avg
Panel avg: 160d · This submission: 206d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HET Device Classification - Class 2, Special Controls

Product Code HET Laparoscope, Gynecologic (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1720
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 - HET Laparoscope, Gynecologic (and Accessories)

All 166
Devices cleared under the same product code (HET) and FDA review panel - the closest regulatory comparables to K954775.
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OES LAPARO-THORACO VIDEOSCOPE TYPE V
K955403 · Olympus America, Inc. · Mar 1996