Cleared Traditional

K861645 - MICRO-TRACHEOSTOMY CARE KIT

K861645 is the FDA 510(k) clearance for MICRO-TRACHEOSTOMY CARE KIT by Aci Medical, Inc.. It is a Class 2 Anesthesiology device (product code BTO) cleared through the Traditional 510(k) pathway after a 9-day FDA review.

K861645 · Aci Medical, Inc. · Anesthesiology device
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May 1986
Decision
9d
Days
Class 2
Risk

K861645 is an FDA 510(k) clearance for the MICRO-TRACHEOSTOMY CARE KIT. Classified as Tube, Tracheostomy (w/wo Connector) (product code BTO), Class II - Special Controls.

Submitted by Aci Medical, Inc. (Sunland, US). The FDA issued a Cleared decision on May 9, 1986 after a review of 9 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5800 - 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 Aci Medical, Inc. devices

Submission Details

510(k) Number K861645 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 1986
Decision Date May 09, 1986
Days to Decision 9 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
131d faster than avg
Panel avg: 140d · This submission: 9d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BTO Tube, Tracheostomy (w/wo Connector)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5800
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 - BTO Tube, Tracheostomy (w/wo Connector)

All 24
Devices cleared under the same product code (BTO) and FDA review panel - the closest regulatory comparables to K861645.
MODIFIED SHILEY LOW PRESSURE CUFFED TRACHEO. TUBES
K880247 · Shiley, Inc. · Feb 1988
JOHNSON INTRATRACHEAL OXYGEN CATHETER SET
K870181 · Cook, Inc. · May 1987
SHILEY DISPOS CANNULA FENES LP CUFFED TRACHE TUBE
K865061 · Shiley, Inc. · Jan 1987
LGT TUBE
K852413 · Mallinckrodt Critical Care · Sep 1985
SHILEY DISPOS. CANNULA FENESTRATED LOW
K843729 · Shiley, Inc. · Oct 1984
SHILEY DISPOS. DECANNULATION PLUG W/SW/
K843730 · Shiley, Inc. · Oct 1984