Cleared Traditional

TRACHEOSTOMY TUBE (K831511) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K831511 · Implant Technology, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1983
Decision
56d
Days
Class 2
Risk

K831511 is an FDA 510(k) clearance for the TRACHEOSTOMY TUBE. Classified as Tube, Tracheostomy (w/wo Connector) (product code BTO), Class II - Special Controls.

Submitted by Implant Technology, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 7, 1983 after a review of 56 days - a notably fast clearance cycle.

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

Submission Details

510(k) Number K831511 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 1983
Decision Date July 07, 1983
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. 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 22
Devices cleared under the same product code (BTO) and FDA review panel - the closest regulatory comparables to K831511.
SHILEY DISPOS. DECANNULATION PLUG W/SW/
K843730 · Shiley, Inc. · Oct 1984
3-DAY BIOINDICATOR RELEASE FOR RESPIR
K833832 · Shiley, Inc. · Mar 1984
DISPOS. LOW PRESS. CUFFED TRACHEOSTOMY
K840539 · Shiley, Inc. · Mar 1984
ARGYLE SILICONE TRACHESTOMY TUBE W/LOW
K831720 · Sherwood Medical Co. · Jul 1983
SHILEY DISPOSABLE CANNULA TRACH. TUBE
K811447 · Shiley, Inc. · Jun 1981
SHILEY LOW PRESSURE THIN-CUFFED TRACH
K811033 · Shiley, Inc. · May 1981