Cleared Traditional

K033614 - MISTIC HUMIDIFICATION SYSTEM 850-00/01/02

K033614 is the FDA 510(k) clearance for MISTIC HUMIDIFICATION SYSTEM 850-00/01/02 by Northgate Technologies, Inc.. It is a Class 2 Obstetrics & Gynecology device (product code HIF) cleared through the Traditional 510(k) pathway after a 255-day FDA review.

K033614 · Northgate Technologies, Inc. · Obstetrics & Gynecology device
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Jul 2004
Decision
255d
Days
Class 2
Risk

K033614 is an FDA 510(k) clearance for the MISTIC HUMIDIFICATION SYSTEM 850-0.... 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 July 29, 2004 after a review of 255 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.

View all Northgate Technologies, Inc. devices

Submission Details

510(k) Number K033614 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 2003
Decision Date July 29, 2004
Days to Decision 255 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
95d slower than avg
Panel avg: 160d · This submission: 255d
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 81
Devices cleared under the same product code (HIF) and FDA review panel - the closest regulatory comparables to K033614.
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FLO-ASSISTANT
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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