Cleared Traditional

OLYMPUS HIGH FLOW INSUFFLATION UNIT (K953162) - FDA 510(k) Clearance

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

K953162 · Olympus America, Inc. · Obstetrics & Gynecology device
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Dec 1995
Decision
165d
Days
Class 2
Risk

K953162 is an FDA 510(k) clearance for the OLYMPUS HIGH FLOW INSUFFLATION UNIT. Classified as Insufflator, Laparoscopic (product code HIF), Class II - Special Controls.

Submitted by Olympus America, Inc. (Melville, US). The FDA issued a Cleared decision on December 19, 1995 after a review of 165 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 Olympus America, Inc. devices

Submission Details

510(k) Number K953162 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 1995
Decision Date December 19, 1995
Days to Decision 165 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
5d slower than avg
Panel avg: 160d · This submission: 165d
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 38
Devices cleared under the same product code (HIF) and FDA review panel - the closest regulatory comparables to K953162.
KSEA N2O ENDOFLATOR
K980134 · KARL STORZ Endoscopy-America, Inc. · Apr 1998
KSEA THERMOFLATOR (MODEL 26 4320 20)
K955073 · KARL STORZ Endoscopy-America, Inc. · Dec 1996
KARL STORZ MODEL 264305-20 ELECTRONIC ENDOFLATOR
K962863 · KARL STORZ Endoscopy-America, Inc. · Nov 1996
ELECTRONIC LAPAROFLATOR
K951694 · KARL STORZ Endoscopy-America, Inc. · Aug 1995
KSEA MODEL 26012CH ELECTRONIC LAPAROFLATOR
K951961 · KARL STORZ Endoscopy-America, Inc. · Aug 1995
KARL STORZ ELECTRONIC LAPAROFLATOR
K934043 · KARL STORZ Endoscopy-America, Inc. · May 1994