Cleared Traditional

K914153 - OTT INSUFFLATOR FILTER PLUS/TUBING SET

K914153 is an FDA 510(k) clearance for OTT INSUFFLATOR FILTER PLUS/TUBING SET, manufactured by Marlo Surgical Technology. The device is a Class 2 Obstetrics & Gynecology device with product code HIF cleared through the Traditional 510(k) pathway after a 199-day FDA review.

K914153 · Marlo Surgical Technology · Obstetrics & Gynecology device
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Apr 1992
Decision
199d
Days
Class 2
Risk

K914153 is an FDA 510(k) clearance for the OTT INSUFFLATOR FILTER PLUS/TUBING SET. Classified as Insufflator, Laparoscopic (product code HIF), Class II - Special Controls.

Submitted by Marlo Surgical Technology (Willoughby, US). The FDA issued a Cleared decision on April 2, 1992 after a review of 199 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 - K914153

510(k) Number K914153 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 1991
Decision Date April 02, 1992
Days to Decision 199 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
38d slower than avg
Panel avg: 161d · This submission: 199d
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 K914153.
MODIFICATION MODEL 7201 INSUFFLATOR
K915051 · Northgate Technologies, Inc. · Jun 1992
SNOWDEN-PENCER HIGH FLOW INSUFFLATOR, SP/88-9700
K920986 · Snowden-Pencer · Jun 1992
CO2 INSUFFLATOR HIGH FLOW ELECTRONIC INSUFFLATOR
K920114 · Spiess Design, Inc. · Apr 1992
SYSTEM 3000 ELECTRONIC INSUFFLATOR
K913873 · Cabot Medical Corp. · Mar 1992
LM- LAP 10 HIGH FLOW INSUFFLATOR
K914201 · Leisegang Medical, Inc. · Jan 1992
IV 1000 INSUFFLATOR RAPID FLOW
K910983 · M.D. Engineering, Inc. · Dec 1991
K914153 · OTT INSUFFLATOR FILTER PLUS/TUBING SET
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