Cleared Traditional

K843490 - TUBE-STAT

K843490 is an FDA 510(k) clearance for TUBE-STAT, manufactured by Concept, Inc.. The device is a Class 1 Anesthesiology device with product code BSR cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K843490 · Concept, Inc. · Anesthesiology device
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Oct 1984
Decision
28d
Days
Class 1
Risk

K843490 is an FDA 510(k) clearance for the TUBE-STAT. Classified as Stylet, Tracheal Tube (product code BSR), Class I - General Controls.

Submitted by Concept, Inc. (Walker, US). The FDA issued a Cleared decision on October 4, 1984 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5790 - 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.

View all Concept, Inc. devices

FDA 510(k) Submission Details - K843490

510(k) Number K843490 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 1984
Decision Date October 04, 1984
Days to Decision 28 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
112d faster than avg
Panel avg: 140d · This submission: 28d
Pathway characteristics
Predicate-based equivalence.

BSR Device Classification - Class 1, General Controls

Product Code BSR Stylet, Tracheal Tube
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5790
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 - BSR Stylet, Tracheal Tube

All 8
Devices cleared under the same product code (BSR) and FDA review panel - the closest regulatory comparables to K843490.
BIVONA ENDOTRACHEAL TUBE STYLET
K905052 · Bivona Medical Technologies · Apr 1991
N-DOGUIDE(TM) ENDOTRACHEAL TUBE INTRODUCING GUIDE
K865108 · Ackrad Laboratories · Feb 1987
ACKRAD ENDOTRACHEAL TUBE INTRODUCING GUIDE
K844557 · Ackrad Laboratories · Dec 1984
SHERI-I-SLIP INTUBATING STYLET
K832773 · Sheridan Catheter Corp. · Sep 1983
INTUBATION PROCEDURE KIT
K772046 · American Hospital Supply Corp. · Nov 1977