Cleared Traditional

K971030 - MIE FALCON, DATEX ENGSTROM FLEXIMA II

K971030 is an FDA 510(k) clearance for MIE FALCON, manufactured by Medical and Industrial Equipment. The device is a Class 2 Anesthesiology device with product code BSZ cleared through the Traditional 510(k) pathway after a 237-day FDA review.

K971030 · Medical and Industrial Equipment · Anesthesiology device
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Nov 1997
Decision
237d
Days
Class 2
Risk

K971030 is an FDA 510(k) clearance for the MIE FALCON, DATEX ENGSTROM FLEXIMA II. Classified as Gas-machine, Anesthesia (product code BSZ), Class II - Special Controls.

Submitted by Medical and Industrial Equipment (Ex2 7na Exeter, GB). The FDA issued a Cleared decision on November 12, 1997 after a review of 237 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 Medical and Industrial Equipment devices

FDA 510(k) Submission Details - K971030

510(k) Number K971030 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 1997
Decision Date November 12, 1997
Days to Decision 237 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
97d slower than avg
Panel avg: 140d · This submission: 237d
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 133
Devices cleared under the same product code (BSZ) and FDA review panel - the closest regulatory comparables to K971030.
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NARKOMED M ANESTHESIA SYSTEM (M)
K971425 · Draeger Medical, Inc. · Sep 1997