Cleared Traditional

K173373 - SafeT T-Piece Resuscitator

K173373 is an FDA 510(k) clearance for SafeT T-Piece Resuscitator, manufactured by Ventlab, LLC. The device is a Class 2 Anesthesiology device with product code BTL cleared through the Traditional 510(k) pathway after a 385-day FDA review.

K173373 · Ventlab, LLC · Anesthesiology device
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Nov 2018
Decision
385d
Days
Class 2
Risk

K173373 is an FDA 510(k) clearance for the SafeT T-Piece Resuscitator. Classified as Ventilator, Emergency, Powered (resuscitator) (product code BTL), Class II - Special Controls.

Submitted by Ventlab, LLC (Grand Rapids, US). The FDA issued a Cleared decision on November 16, 2018 after a review of 385 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5925 - 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Ventlab, LLC devices

FDA 510(k) Submission Details - K173373

510(k) Number K173373 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 2017
Decision Date November 16, 2018
Days to Decision 385 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
245d slower than avg
Panel avg: 140d · This submission: 385d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTL Device Classification - Class 2, Special Controls

Product Code BTL Ventilator, Emergency, Powered (resuscitator)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5925
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 - BTL Ventilator, Emergency, Powered (resuscitator)

All 68
Devices cleared under the same product code (BTL) and FDA review panel - the closest regulatory comparables to K173373.
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