Cleared Traditional

K002343 - SIGMA DELTA

K002343 is an FDA 510(k) clearance for SIGMA DELTA, manufactured by Penlon , Ltd.. The device is a Class 2 Anesthesiology device with product code CAD cleared through the Traditional 510(k) pathway after a 311-day FDA review.

K002343 · Penlon , Ltd. · Anesthesiology device
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Jun 2001
Decision
311d
Days
Class 2
Risk

K002343 is an FDA 510(k) clearance for the SIGMA DELTA. Classified as Vaporizer, Anesthesia, Non-heated (product code CAD), Class II - Special Controls.

Submitted by Penlon , Ltd. (Barton Lane, Abingdon, GB). The FDA issued a Cleared decision on June 8, 2001 after a review of 311 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 , Ltd. devices

FDA 510(k) Submission Details - K002343

510(k) Number K002343 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2000
Decision Date June 08, 2001
Days to Decision 311 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
171d slower than avg
Panel avg: 140d · This submission: 311d
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 K002343.
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
DATEX-OHMEDA TEC 6 PLUS ANESTHESIA VAPORIZER, DATEX-OHMEDA TEC 6 PLUS NAD VARIANT ANESTHESIA
K000275 · Datex-Ohmeda, Inc. · Apr 2000
DATEX-OHMEDA ANESTHESIA VAPORIZER, MODEL D-TEC
K990132 · Datex-Ohmeda, Inc. · Jan 1999