Cleared Traditional

K161719 - Salter Labs Bubble Humidifier

K161719 is an FDA 510(k) clearance for Salter Labs Bubble Humidifier, manufactured by Salter Labs. The device is a Class 2 Anesthesiology device with product code BTT cleared through the Traditional 510(k) pathway after a 456-day FDA review.

K161719 · Salter Labs · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2017
Decision
456d
Days
Class 2
Risk

K161719 is an FDA 510(k) clearance for the Salter Labs Bubble Humidifier. Classified as Humidifier, Respiratory Gas, (direct Patient Interface) (product code BTT), Class II - Special Controls.

Submitted by Salter Labs (Carlsbad, US). The FDA issued a Cleared decision on September 21, 2017 after a review of 456 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5450 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all Salter Labs devices

FDA 510(k) Submission Details - K161719

510(k) Number K161719 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 2016
Decision Date September 21, 2017
Days to Decision 456 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
316d slower than avg
Panel avg: 140d · This submission: 456d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTT Device Classification - Class 2, Special Controls

Product Code BTT Humidifier, Respiratory Gas, (direct Patient Interface)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5450
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 - BTT Humidifier, Respiratory Gas, (direct Patient Interface)

All 109
Devices cleared under the same product code (BTT) and FDA review panel - the closest regulatory comparables to K161719.
Palladium High Flow Therapy System
K191010 · Vapotherm, Inc. · Oct 2019
AirSpiral Heated Breathing Tube
K162553 · Fisher & Paykel Healthcare · Dec 2018
TNI softFlow 50
K180474 · Tni Medical AG · Oct 2018
HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010
K163283 · Hamilton Medical AG · Sep 2017
Comfort Flo Humidification System
K162242 · Teleflexmedical, Inc. · Jan 2017
HAMILTON-H900, HAMILTON-BC8022, HAMILTON-BC4022, HAMILTON-BC8010, HAMILTON-BC4010
K152029 · Hamilton Medical AG · May 2016