Cleared Traditional

K122705 - HUMICARE D900

K122705 is an FDA 510(k) clearance for HUMICARE D900, manufactured by Grundler GmbH. The device is a Class 2 Anesthesiology device with product code BTT cleared through the Traditional 510(k) pathway after a 259-day FDA review.

K122705 · Grundler GmbH · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2013
Decision
259d
Days
Class 2
Risk

K122705 is an FDA 510(k) clearance for the HUMICARE D900. Classified as Humidifier, Respiratory Gas, (direct Patient Interface) (product code BTT), Class II - Special Controls.

Submitted by Grundler GmbH (San Diego, US). The FDA issued a Cleared decision on May 21, 2013 after a review of 259 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K122705

510(k) Number K122705 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 2012
Decision Date May 21, 2013
Days to Decision 259 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
119d slower than avg
Panel avg: 140d · This submission: 259d
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

Tuv Sud America, Inc.
OLAF TEICHERT

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 179
Devices cleared under the same product code (BTT) and FDA review panel - the closest regulatory comparables to K122705.
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AIRVO HUMIDIFIER MYAIRO HUMIDIFIER
K121975 · Fisher &Paykel Healthcare , Ltd. · Jan 2013
RESPIRATORY HUMIDIFER
K110019 · Fisher &Paykel Healthcare , Ltd. · Mar 2012
SALTER LABS BUBBLE HUMIDIFIER (HIGH FLOW)
K113542 · Salter Labs, Arvin Facility · Feb 2012