Cleared Traditional

K030837 - 40 L HIGH FLOW INSUFFLATOR F108

K030837 is an FDA 510(k) clearance for 40 L HIGH FLOW INSUFFLATOR F108, manufactured by W.O.M. World of Medicine AG. The device is a Class 2 Obstetrics & Gynecology device with product code HIF cleared through the Traditional 510(k) pathway after a 325-day FDA review.

K030837 · W.O.M. World of Medicine AG · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2004
Decision
325d
Days
Class 2
Risk

K030837 is an FDA 510(k) clearance for the 40 L HIGH FLOW INSUFFLATOR F108. Classified as Insufflator, Laparoscopic (product code HIF), Class II - Special Controls.

Submitted by W.O.M. World of Medicine AG (Alexandria, US). The FDA issued a Cleared decision on February 5, 2004 after a review of 325 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1730 - 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. Elevated predicate reliance profile. 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 W.O.M. World of Medicine AG devices

FDA 510(k) Submission Details - K030837

510(k) Number K030837 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 2003
Decision Date February 05, 2004
Days to Decision 325 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
165d slower than avg
Panel avg: 160d · This submission: 325d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HIF Device Classification - Class 2, Special Controls

Product Code HIF Insufflator, Laparoscopic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1730
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 - HIF Insufflator, Laparoscopic

All 83
Devices cleared under the same product code (HIF) and FDA review panel - the closest regulatory comparables to K030837.
KSEA ELECTRONIC CO2 ENDOFLATOR LC, MODEL 26430320-1
K080852 · KARL STORZ Endoscopy-America, Inc. · Mar 2009
FLO-ASSISTANT
K041560 · Northgate Technologies, Inc. · Sep 2004
MISTIC HUMIDIFICATION SYSTEM 850-00/01/02, 2215
K033614 · Northgate Technologies, Inc. · Jul 2004
40LPM ABDOMINAL INSUFFLATOR, CATALOG # 72-00203-0
K022052 · Northgate Technologies, Inc. · Jan 2003
HUMI-FLOW, MODEL 6-850-00/ 01/02
K010053 · Northgate Technologies, Inc. · Oct 2001
SIOS-INTERFACE FOR AUTO LIGHT PROJECTOR, SIOS-INTERFACE FOR 3 CCD ENDOCAM, SIOS-INTERFACE FOR LAPARO CO2 INSUFFLATOR
K002328 · Richard Wolf Medical Instruments Corp. · Aug 2001