Cleared Traditional

K172702 - Tec 820

K172702 is the FDA 510(k) clearance for Tec 820 by Datex-Ohmeda, Inc.. It is a Class 2 Anesthesiology device (product code CAD) cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K172702 · Datex-Ohmeda, Inc. · Anesthesiology device
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Jan 2018
Decision
119d
Days
Class 2
Risk

K172702 is an FDA 510(k) clearance for the Tec 820, Tec 850. Classified as Vaporizer, Anesthesia, Non-heated (product code CAD), Class II - Special Controls.

Submitted by Datex-Ohmeda, Inc. (Madison, US). The FDA issued a Cleared decision on January 4, 2018 after a review of 119 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5880 - the FDA anesthesiology and respiratory 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 Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Datex-Ohmeda, Inc. devices

Submission Details

510(k) Number K172702 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 2017
Decision Date January 04, 2018
Days to Decision 119 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 140d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CAD Vaporizer, Anesthesia, Non-heated
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5880
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 Anesthesiology devices follow this clearance model.

Regulatory Peers - CAD Vaporizer, Anesthesia, Non-heated

All 23
Devices cleared under the same product code (CAD) and FDA review panel - the closest regulatory comparables to K172702.
V80 Anesthetic Vaporizer (V80)
K240375 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Oct 2024
V60 Anesthetic Vaporizer
K150167 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Jun 2015
D-VAPOR
K042276 · Draeger Medical, Inc. · Sep 2004
DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER (ENFLURANE)
K031027 · Datex-Ohmeda, Inc. · Jun 2003
DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER
K012924 · Datex-Ohmeda, Inc. · Jan 2002
DATEX-OHMEDA D-TEC PLUS ANESTHESIA VAPORIZER
K002878 · Datex-Ohmeda, Inc. · Sep 2000