Cleared Traditional

40 L HIGH FLOW INSUFFLATOR F108 (K030837) - FDA 510(k) Clearance

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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 46
Devices cleared under the same product code (HIF) and FDA review panel - the closest regulatory comparables to K030837.
ENDOFLATOR 40, ENDOFLATOR 50
K161554 · KARL STORZ Endoscopy-America, Inc. · Mar 2017
MEDLINE PNEUMOPERITONEUM NEEDLE
K111955 · Medline Industries, Inc. · Nov 2011
KSEA ELECTRONIC CO2 ENDOFLATOR LC, MODEL 26430320-1
K080852 · KARL STORZ Endoscopy-America, Inc. · Mar 2009
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
TRANSANAL ENDOSCOPIC MICROSURGERY (TEM) COMBINATION SYSTEM AND INSTRUMENT SET, INSTRUMENT SET FOR THE TRANSANAL ENDOSCOP
K000180 · Richard Wolf Medical Instruments Corp. · Mar 2001
LAPARO CO2-PNEU AUTOMATIC INSUFFLATOR WITH 30L FLOW RATE,AND VIDEO-SCREEN DISPLAY, HIGH FLOW INSUFFLATION TUBE WITH HEAT
K991906 · Richard Wolf Medical Instruments Corp. · Nov 1999