Cleared Traditional

K903404 - FLOCARE F

K903404 is an FDA 510(k) clearance for FLOCARE F, manufactured by Flocare Medical. The device is a Class 1 Anesthesiology device with product code BZO cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K903404 · Flocare Medical · Anesthesiology device
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Sep 1990
Decision
56d
Days
Class 1
Risk

K903404 is an FDA 510(k) clearance for the FLOCARE F. Classified as Set, Tubing And Support, Ventilator (w Harness) (product code BZO), Class I - General Controls.

Submitted by Flocare Medical (Wayne, US). The FDA issued a Cleared decision on September 25, 1990 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5975 - 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 - K903404

510(k) Number K903404 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 1990
Decision Date September 25, 1990
Days to Decision 56 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 140d · This submission: 56d
Pathway characteristics
Predicate-based equivalence.

BZO Device Classification - Class 1, General Controls

Product Code BZO Set, Tubing And Support, Ventilator (w Harness)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5975
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - BZO Set, Tubing And Support, Ventilator (w Harness)

All 58
Devices cleared under the same product code (BZO) and FDA review panel - the closest regulatory comparables to K903404.
DISPOSABLE ANESTHESIA BREATHING CIRCUIT, MODIFIED
K922479 · Intertech Resources, Inc. · Oct 1992
GAS SAMPLING KIT MODIFICATION
K921510 · Respiratory Support Products, Inc. · Jun 1992
UNIVERSAL VOLUME VENTILATOR CIRCUIT, MODIFICATION
K911328 · Intertech Resources, Inc. · Aug 1991
TUBING FLEXIBLE MEDICAL GAS LOW-PRESSURE
K896439 · Ventlab Corp. · Jan 1990
SECHRIST DISPOSABLE INFANT BREATHING CIRCUIT
K895853 · Sechrist Industries, Inc. · Dec 1989
CRITERION I.V. VENTILATOR BREATHING CIRCUIT #1004
K893760 · Nova-Ventrx · Aug 1989
K903404 · FLOCARE F
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