Cleared Traditional

TEMED Gas Diffuser (K173545) - FDA 510(k) Clearance

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

K173545 · Temed · Obstetrics & Gynecology device
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Feb 2018
Decision
90d
Days
Class 2
Risk

K173545 is an FDA 510(k) clearance for the TEMED Gas Diffuser. Classified as Insufflator, Laparoscopic (product code HIF), Class II - Special Controls.

Submitted by Temed (Sidlesham, GB). The FDA issued a Cleared decision on February 14, 2018 after a review of 90 days - within the typical 510(k) review window.

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 Temed devices

Submission Details

510(k) Number K173545 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 2017
Decision Date February 14, 2018
Days to Decision 90 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
70d faster than avg
Panel avg: 160d · This submission: 90d
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 49
Devices cleared under the same product code (HIF) and FDA review panel - the closest regulatory comparables to K173545.
AirSeal
K190303 · Conmed Corporation · Mar 2019
GRI-Alleset Veress Needle
K172835 · Gri Medical and Electronic Technology Co., Ltd. · Jun 2018
SurgiQuest AIRSEAL iFS System
K172516 · Conmed Corporation · Mar 2018
ENDOFLATOR 40, ENDOFLATOR 50
K161554 · KARL STORZ Endoscopy-America, Inc. · Mar 2017
MEDLINE PNEUMOPERITONEUM NEEDLE
K111955 · Medline Industries, Inc. · Nov 2011
KSEA ELECTRONIC CO2 ENDOFLATOR LC, MODEL 26430320-1
K080852 · KARL STORZ Endoscopy-America, Inc. · Mar 2009