Cleared Traditional

K031014 - HI-FLO THERME PNEU 45, WISAP #7083, 7083V

K031014 is an FDA 510(k) clearance for HI-FLO THERME PNEU 45, manufactured by Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh. The device is a Class 2 Obstetrics & Gynecology device with product code HIF cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K031014 · Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
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Jun 2003
Decision
88d
Days
Class 2
Risk

K031014 is an FDA 510(k) clearance for the HI-FLO THERME PNEU 45, WISAP #7083, 7083V. Classified as Insufflator, Laparoscopic (product code HIF), Class II - Special Controls.

Submitted by Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh (Sauerlach, DE). The FDA issued a Cleared decision on June 27, 2003 after a review of 88 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh devices

FDA 510(k) Submission Details - K031014

510(k) Number K031014 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2003
Decision Date June 27, 2003
Days to Decision 88 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
72d faster than avg
Panel avg: 160d · This submission: 88d
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 106
Devices cleared under the same product code (HIF) and FDA review panel - the closest regulatory comparables to K031014.
SOPRO MODEL 640 LAPAROSCOPIC INSUFFLATOR
K070783 · Sopro · Dec 2007
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
UHI-3 HIGH FLOW INSUFFLATION UNIT
K014166 · Olympus Optical Co., Ltd. · Jun 2002
HUMI-FLOW, MODEL 6-850-00/ 01/02
K010053 · Northgate Technologies, Inc. · Oct 2001