Cleared Traditional

K113542 - SALTER LABS BUBBLE HUMIDIFIER (HIGH FLOW)

K113542 is an FDA 510(k) clearance for SALTER LABS BUBBLE HUMIDIFIER (HIGH FLOW), manufactured by Salter Labs, Arvin Facility. The device is a Class 2 Anesthesiology device with product code BTT cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K113542 · Salter Labs, Arvin Facility · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2012
Decision
71d
Days
Class 2
Risk

K113542 is an FDA 510(k) clearance for the SALTER LABS BUBBLE HUMIDIFIER (HIGH FLOW). Classified as Humidifier, Respiratory Gas, (direct Patient Interface) (product code BTT), Class II - Special Controls.

Submitted by Salter Labs, Arvin Facility (Arvin, US). The FDA issued a Cleared decision on February 10, 2012 after a review of 71 days - a notably fast clearance cycle.

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: 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 Salter Labs, Arvin Facility devices

FDA 510(k) Submission Details - K113542

510(k) Number K113542 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 2011
Decision Date February 10, 2012
Days to Decision 71 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 140d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Underwriters Laboratories, Inc.
CASEY CONRY

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - BTT Humidifier, Respiratory Gas, (direct Patient Interface)

All 172
Devices cleared under the same product code (BTT) and FDA review panel - the closest regulatory comparables to K113542.
HUMICARE D900
K122705 · Grundler GmbH · May 2013
AIRVO HUMIDIFIER MYAIRO HUMIDIFIER
K121975 · Fisher &Paykel Healthcare , Ltd. · Jan 2013
RESPIRATORY HUMIDIFER
K110019 · Fisher &Paykel Healthcare , Ltd. · Mar 2012
PRECISION FLOW(R) - HELIOX
K111640 · Vapotherm, Inc. · Oct 2011
FLOWREST
K103316 · Vapotherm, Inc. · Feb 2011
VENTLAB 6000 SERIES HUMIDIFIER
K093617 · Ventlab Corp. · Jan 2011