Cleared Traditional

K060331 - SIGMA ALPHA VAPORIZER

K060331 is an FDA 510(k) clearance for SIGMA ALPHA VAPORIZER, manufactured by Penlon Limited. The device is a Class 2 Anesthesiology device with product code CAD cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K060331 · Penlon Limited · Anesthesiology device
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May 2006
Decision
90d
Days
Class 2
Risk

K060331 is an FDA 510(k) clearance for the SIGMA ALPHA VAPORIZER. Classified as Vaporizer, Anesthesia, Non-heated (product code CAD), Class II - Special Controls.

Submitted by Penlon Limited (West Sussex, GB). The FDA issued a Cleared decision on May 10, 2006 after a review of 90 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 Penlon Limited devices

FDA 510(k) Submission Details - K060331

510(k) Number K060331 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 2006
Decision Date May 10, 2006
Days to Decision 90 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
50d faster than avg
Panel avg: 140d · This submission: 90d
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 25
Devices cleared under the same product code (CAD) and FDA review panel - the closest regulatory comparables to K060331.
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
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