Cleared Traditional

K800801 - ANALGESIA UNITS, OXYGEN & NITRATE DEVICE

K800801 is an FDA 510(k) clearance for ANALGESIA UNITS, manufactured by Spica, Inc.. The device is a Class 2 Anesthesiology device with product code BSZ cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K800801 · Spica, Inc. · Anesthesiology device
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May 1980
Decision
48d
Days
Class 2
Risk

K800801 is an FDA 510(k) clearance for the ANALGESIA UNITS, OXYGEN & NITRATE DEVICE. Classified as Gas-machine, Anesthesia (product code BSZ), Class II - Special Controls.

Submitted by Spica, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 28, 1980 after a review of 48 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K800801

510(k) Number K800801 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 1980
Decision Date May 28, 1980
Days to Decision 48 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 140d · This submission: 48d
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 163
Devices cleared under the same product code (BSZ) and FDA review panel - the closest regulatory comparables to K800801.
MODULUS II ANESTHESIA GAS MACHINE
K833335 · Ohio Medical Products · Nov 1983
AIR-SHIELDS VENTIMETER VENTILATOR-CONTR
K830680 · Narco Scientific · Apr 1983
NARKOMED 2A ANESTHESIA MACHINE
K822218 · Draeger Medical, Inc. · Sep 1982
OHIO MODULAR ANESTHESIA GAS MACHINE
K791530 · Ohio Medical Products · Sep 1979
CONTINUOUS FLOW ANESTHESIA MACHINE
K771989 · Draeger Medical, Inc. · Nov 1977
NITROX 30 - ANESTHETIC GAS PROPORTIONER
K771479 · Ohio Medical Products · Nov 1977
K800801 · ANALGESIA UNITS, OXYGEN & NITRATE DEVICE
Download PDF Spica, Inc.