Cleared Traditional

K864590 - AM1000

K864590 is an FDA 510(k) clearance for AM1000, manufactured by Bear Medical Systems, Inc.. The device is a Class 2 Anesthesiology device with product code BSZ cleared through the Traditional 510(k) pathway after a 164-day FDA review.

K864590 · Bear Medical Systems, Inc. · Anesthesiology device
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May 1987
Decision
164d
Days
Class 2
Risk

K864590 is an FDA 510(k) clearance for the AM1000. Classified as Gas-machine, Anesthesia (product code BSZ), Class II - Special Controls.

Submitted by Bear Medical Systems, Inc. (Riverside, US). The FDA issued a Cleared decision on May 4, 1987 after a review of 164 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 Bear Medical Systems, Inc. devices

FDA 510(k) Submission Details - K864590

510(k) Number K864590 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 1986
Decision Date May 04, 1987
Days to Decision 164 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
24d slower than avg
Panel avg: 140d · This submission: 164d
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 118
Devices cleared under the same product code (BSZ) and FDA review panel - the closest regulatory comparables to K864590.
REVISED PNEUMATIC DIAGRAMS FOR MODULUS II PLUS
K882489 · Ohmeda Medical · Jul 1988
OHMEDA MODULUS II PLUS ANESTHESIA SYSTEM
K875350 · Ohmeda Medical · Mar 1988
TRI-SERVICE OMV VAPORIZER
K864589 · Bear Medical Systems, Inc. · Jun 1987
NARKOMED 2B ANESTHESIA SYSTEM
K864447 · Draeger Medical, Inc. · Jan 1987
ANESTHESIA RECORDER
K864806 · Draeger Medical, Inc. · Jan 1987
OHMEDA 'B' SERIES GAS DELIVERY SYSTEM
K863207 · Ohmeda Medical · Oct 1986