Cleared Traditional

K010053 - HUMI-FLOW, MODEL 6-850-00/ 01/02

K010053 is an FDA 510(k) clearance for HUMI-FLOW, manufactured by Northgate Technologies, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HIF cleared through the Traditional 510(k) pathway after a 288-day FDA review.

K010053 · Northgate Technologies, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2001
Decision
288d
Days
Class 2
Risk

K010053 is an FDA 510(k) clearance for the HUMI-FLOW, MODEL 6-850-00/ 01/02. Classified as Insufflator, Laparoscopic (product code HIF), Class II - Special Controls.

Submitted by Northgate Technologies, Inc. (Elgin, US). The FDA issued a Cleared decision on October 23, 2001 after a review of 288 days - an extended review 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: 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.

FDA 510(k) Submission Details - K010053

510(k) Number K010053 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 08, 2001
Decision Date October 23, 2001
Days to Decision 288 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
127d slower than avg
Panel avg: 161d · This submission: 288d
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 178
Devices cleared under the same product code (HIF) and FDA review panel - the closest regulatory comparables to K010053.
VOMED ENDOSCOPIC AND UROLOGICAL ACCESSORIES
K022318 · Vomed Volzer Medizintechnik GmbH & Co. · Sep 2002
UHI-3 HIGH FLOW INSUFFLATION UNIT
K014166 · Olympus Optical Co., Ltd. · Jun 2002
MULTI HI-FLO PNEU, WISAP #7080
K011510 · Wisap Gesellschaft Fur Wissenschaftl. App. Bau Mbh · Apr 2002
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
TAUT-INSUFFLATION NEEDLE
K003703 · Taut, Inc. · Feb 2001
K010053 · HUMI-FLOW, MODEL 6-850-00/ 01/02
Download PDF FDA Summary Northgate Technologie…