Cleared Traditional

K981530 - SPACELABS MEDICAL 90519 ANESTHESIA DELI...

K981530 is an FDA 510(k) clearance for SPACELABS MEDICAL 90519 ANESTHESIA DELI..., 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 205-day FDA review.

K981530 · Spacelabs Medical, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
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Nov 1998
Decision
205d
Days
Class 2
Risk

K981530 is an FDA 510(k) clearance for the SPACELABS MEDICAL 90519 ANESTHESIA DELIVERY SYSTEM. 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 November 20, 1998 after a review of 205 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 - K981530

510(k) Number K981530 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 1998
Decision Date November 20, 1998
Days to Decision 205 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
65d slower than avg
Panel avg: 140d · This submission: 205d
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 110
Devices cleared under the same product code (BSZ) and FDA review panel - the closest regulatory comparables to K981530.
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NARKOMED 6000 MODEL NUMBER NM6000
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OHMEDA EXCEL 3000 ANESTHESIA SYSTEM
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PERIOPERATIVE DATA MANAGEMENT SYSTEM
K973949 · Draeger Medical, Inc. · Feb 1998