Cleared Traditional

K110608 - SEVOFLURANE VAPORIZER ADAPTOR

K110608 is an FDA 510(k) clearance for SEVOFLURANE VAPORIZER ADAPTOR, manufactured by Piramal Critcal Care, Inc (Formerly Minrad, Inc). The device is a Class 2 Anesthesiology device with product code CAD cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K110608 · Piramal Critcal Care, Inc (Formerly Minrad, Inc) · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2011
Decision
139d
Days
Class 2
Risk

K110608 is an FDA 510(k) clearance for the SEVOFLURANE VAPORIZER ADAPTOR. Classified as Vaporizer, Anesthesia, Non-heated (product code CAD), Class II - Special Controls.

Submitted by Piramal Critcal Care, Inc (Formerly Minrad, Inc) (Orchard Park, US). The FDA issued a Cleared decision on July 20, 2011 after a review of 139 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.

FDA 510(k) Submission Details - K110608

510(k) Number K110608 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 2011
Decision Date July 20, 2011
Days to Decision 139 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
1d faster than avg
Panel avg: 140d · This submission: 139d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CAD Device Classification - Class 2, Special Controls

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 41
Devices cleared under the same product code (CAD) and FDA review panel - the closest regulatory comparables to K110608.
V80 Anesthetic Vaporizer (V80)
K240375 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Oct 2024
Tec 820, Tec 850
K172702 · Datex-Ohmeda, Inc. · Jan 2018
V60 Anesthetic Vaporizer
K150167 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Jun 2015
SIGMA ALPHA VAPORIZER
K060331 · Penlon Limited · May 2006
KEYED FILLER BOTTLE ADAPTOR, MODELS 53450, 53452, 53453, 53454
K053564 · Penlon Limited · Mar 2006
GAV - GENERAL ANAESTHETIC VAPORIZER
K051666 · General Anaesthetic Services Limited · Aug 2005