Cleared Traditional

K121028 - ETVIEW TRACHEOSCOPIC VENTILATION TUBE (TVT(TM))

K121028 is an FDA 510(k) clearance for ETVIEW TRACHEOSCOPIC VENTILATION TUBE (..., manufactured by Etview , Ltd.. The device is a Class 2 Anesthesiology device with product code BTR cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K121028 · Etview , Ltd. · Anesthesiology device
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Jun 2012
Decision
77d
Days
Class 2
Risk

K121028 is an FDA 510(k) clearance for the ETVIEW TRACHEOSCOPIC VENTILATION TUBE (TVT(TM)). Classified as Tube, Tracheal (w/wo Connector) (product code BTR), Class II - Special Controls.

Submitted by Etview , Ltd. (Binyamina, IL). The FDA issued a Cleared decision on June 21, 2012 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5730 - 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 Etview , Ltd. devices

FDA 510(k) Submission Details - K121028

510(k) Number K121028 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 2012
Decision Date June 21, 2012
Days to Decision 77 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 140d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTR Device Classification - Class 2, Special Controls

Product Code BTR Tube, Tracheal (w/wo Connector)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5730
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 - BTR Tube, Tracheal (w/wo Connector)

All 176
Devices cleared under the same product code (BTR) and FDA review panel - the closest regulatory comparables to K121028.
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