Cleared Traditional

K132903 - DRE VENTURA

K132903 is an FDA 510(k) clearance for DRE VENTURA, manufactured by Dre Medical, Inc.. The device is a Class 2 Anesthesiology device with product code BSZ cleared through the Traditional 510(k) pathway after a 288-day FDA review.

K132903 · Dre Medical, Inc. · Anesthesiology device
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Jul 2014
Decision
288d
Days
Class 2
Risk

K132903 is an FDA 510(k) clearance for the DRE VENTURA. Classified as Gas-machine, Anesthesia (product code BSZ), Class II - Special Controls.

Submitted by Dre Medical, Inc. (Louisville, US). The FDA issued a Cleared decision on July 1, 2014 after a review of 288 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5160 - 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 Dre Medical, Inc. devices

FDA 510(k) Submission Details - K132903

510(k) Number K132903 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 2013
Decision Date July 01, 2014
Days to Decision 288 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
148d slower than avg
Panel avg: 140d · This submission: 288d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BSZ Device Classification - Class 2, Special Controls

Product Code BSZ Gas-machine, Anesthesia
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5160
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 - BSZ Gas-machine, Anesthesia

All 115
Devices cleared under the same product code (BSZ) and FDA review panel - the closest regulatory comparables to K132903.
A7 Anesthesia System
K151954 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Oct 2015
Aespire View
K143530 · Datex-Ohmeda, Inc. · Apr 2015
A7 Anesthesia System
K142552 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Jan 2015
FLOW-I ANESTHESIA SYSTEM C20, C30 & C40
K133958 · Maquet Critical Care AB · Mar 2014
GE DATEX-OHMEDA AISYS CS2 (AISYS CS^2)
K132530 · Datex-Ohmeda, Inc. · Dec 2013
GE DATEX-OHMEDA AVANCE CS2
K131945 · Datex-Ohmeda · Aug 2013