Cleared Traditional

K853828 - FLS MED. PROD. RACINE TYPE ADAPTOR

K853828 is an FDA 510(k) clearance for FLS MED. PROD. RACINE TYPE ADAPTOR, manufactured by Fls Medical Products, Inc.. The device is a Class 1 Anesthesiology device with product code BZA cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K853828 · Fls Medical Products, Inc. · Anesthesiology device
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Oct 1985
Decision
46d
Days
Class 1
Risk

K853828 is an FDA 510(k) clearance for the FLS MED. PROD. RACINE TYPE ADAPTOR. Classified as Connector, Airway (extension) (product code BZA), Class I - General Controls.

Submitted by Fls Medical Products, Inc. (Pinellas Park, US). The FDA issued a Cleared decision on October 29, 1985 after a review of 46 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5810 - 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 - K853828

510(k) Number K853828 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 1985
Decision Date October 29, 1985
Days to Decision 46 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 140d · This submission: 46d
Pathway characteristics
Predicate-based equivalence.

BZA Device Classification - Class 1, General Controls

Product Code BZA Connector, Airway (extension)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5810
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 - BZA Connector, Airway (extension)

All 73
Devices cleared under the same product code (BZA) and FDA review panel - the closest regulatory comparables to K853828.
STRAIGHT CONNECTORS, 22MM
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K860887 · Dhd Medical Products Div. Diemolding Corp. · Mar 1986
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K860888 · Dhd Medical Products Div. Diemolding Corp. · Mar 1986
DOUBLE-SWIVEL CONNECTOR
K850964 · Sheridan Catheter Corp. · May 1985
ARGYLE 15MM SWIVEL CONNECTOR
K850625 · Sherwood Medical Co. · Mar 1985
OHMEDA DOUBLE SWIVEL ADAPTER
K844656 · Ohmeda Medical · Feb 1985
K853828 · FLS MED. PROD. RACINE TYPE ADAPTOR
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