Cleared Traditional

K003663 - SPACELABS MEDICAL ANESTHESIA DELIVERY SYSTEM (ADS) WITH PRESSURE CONTROL MODE

K003663 is an FDA 510(k) clearance for SPACELABS MEDICAL ANESTHESIA DELIVERY S..., manufactured by Spacelabs Medical, Inc.. The device is a Class 2 Anesthesiology device with product code BSZ cleared through the Traditional 510(k) pathway after a 212-day FDA review.

K003663 · Spacelabs Medical, Inc. · Anesthesiology device
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Jun 2001
Decision
212d
Days
Class 2
Risk

K003663 is an FDA 510(k) clearance for the SPACELABS MEDICAL ANESTHESIA DELIVERY SYSTEM (ADS) WITH PRESSURE CONTROL MODE. Classified as Gas-machine, Anesthesia (product code BSZ), Class II - Special Controls.

Submitted by Spacelabs Medical, Inc. (Redmond, US). The FDA issued a Cleared decision on June 28, 2001 after a review of 212 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 Spacelabs Medical, Inc. devices

FDA 510(k) Submission Details - K003663

510(k) Number K003663 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 2000
Decision Date June 28, 2001
Days to Decision 212 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
72d slower than avg
Panel avg: 140d · This submission: 212d
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 153
Devices cleared under the same product code (BSZ) and FDA review panel - the closest regulatory comparables to K003663.
FABIUS GS ANESTHESIA SYSTEM, MODEL FABIUS GS
K011404 · Draeger Medical, Inc. · Feb 2002
MAGELLAN-2200, MODEL 1
K010613 · Oceanic Medical Products, Inc. · Oct 2001
OFFICE BASED ANESTHESIA MACHINE MRI, MODEL OBA-1 MRI
K012446 · Charles A. Smith · Oct 2001
BLEASE FRONTLINE PLUS RANGE, ANESTHESIA MACHINES, MODEL 440, 560 AND 690
K003251 · Blease Medical Equipment , Ltd. · May 2001
MODULAR
K001988 · Heyer America, Inc. · Feb 2001
NARKOMED MRI-2, MODEL NM-MRI-2
K003579 · Draeger Medical, Inc. · Jan 2001