Cleared Traditional

K110852 - DOLPHIN 3 FLUID MANAGEMENT SYSTEM

K110852 is an FDA 510(k) clearance for DOLPHIN 3 FLUID MANAGEMENT SYSTEM, manufactured by Gyrus Acmi, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HIG cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K110852 · Gyrus Acmi, Inc. · Obstetrics & Gynecology device
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Jul 2011
Decision
113d
Days
Class 2
Risk

K110852 is an FDA 510(k) clearance for the DOLPHIN 3 FLUID MANAGEMENT SYSTEM. Classified as Insufflator, Hysteroscopic (product code HIG), Class II - Special Controls.

Submitted by Gyrus Acmi, Inc. (Southborough, US). The FDA issued a Cleared decision on July 19, 2011 after a review of 113 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1700 - 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 Gyrus Acmi, Inc. devices

FDA 510(k) Submission Details - K110852

510(k) Number K110852 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 2011
Decision Date July 19, 2011
Days to Decision 113 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
47d faster than avg
Panel avg: 160d · This submission: 113d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HIG Device Classification - Class 2, Special Controls

Product Code HIG Insufflator, Hysteroscopic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1700
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 - HIG Insufflator, Hysteroscopic

All 42
Devices cleared under the same product code (HIG) and FDA review panel - the closest regulatory comparables to K110852.
THERMEDX FLUID MANAGMENT SYSTEM
K133799 · Thermedx, LLC · Jun 2014
HYSTEROSCOPY PUMP HM6
K123732 · W.O.M. World of Medicine AG · Apr 2013
AQUILEX FLUID CONTROL SYSTEM H112
K112642 · W.O.M. World of Medicine AG · Feb 2012
AQUASENS FLUID MONITORING SYSTEM
K031213 · Davol, Inc. · Apr 2003
AQUASENS FLUID MONITORING SYSTEM
K011069 · Davol Inc., Sub. C. R. Bard, Inc. · Aug 2001
KARL STORZ HYSTEROMAT II
K000806 · KARL STORZ Endoscopy-America, Inc. · Nov 2000