Cleared Traditional

K251419 - Laboratorios Biogalenic Sterile Water f...

K251419 is an FDA 510(k) clearance for Laboratorios Biogalenic Sterile Water f..., manufactured by Laboratorios Biogalenic S.A. DE C.V.. The device is a Class 2 Anesthesiology device with product code BTT cleared through the Traditional 510(k) pathway after a 252-day FDA review.

K251419 · Laboratorios Biogalenic S.A. DE C.V. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2026
Decision
252d
Days
Class 2
Risk

K251419 is an FDA 510(k) clearance for the Laboratorios Biogalenic Sterile Water for Inhalation, USP. Classified as Humidifier, Respiratory Gas, (direct Patient Interface) (product code BTT), Class II - Special Controls.

Submitted by Laboratorios Biogalenic S.A. DE C.V. (San Salvador, SV). The FDA issued a Cleared decision on January 14, 2026 after a review of 252 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.

View all Laboratorios Biogalenic S.A. DE C.V. devices

FDA 510(k) Submission Details - K251419

510(k) Number K251419 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 2025
Decision Date January 14, 2026
Days to Decision 252 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
112d slower than avg
Panel avg: 140d · This submission: 252d
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 Consultant

Herschel J. Gaddy & Associates
Jennifer Prussman

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 109
Devices cleared under the same product code (BTT) and FDA review panel - the closest regulatory comparables to K251419.
HVT 2.0
K254078 · Vapotherm, Inc. · Apr 2026
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K251448 · Flexicare Medical Limited. · Jan 2026
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K253479 · Fisher &Paykel Healthcare , Ltd. · Dec 2025
Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant
K250312 · Medline Industries, LP · Jul 2025
Optiflow+ Nasal Cannula - Small (OPT942)
K251611 · Fisher &Paykel Healthcare , Ltd. · Jun 2025
Laboratorios Biogalenic Sterile Water for Inhalation, USP
K242717 · Laboratorios Biogalenic S.A. DE C.V. · Jan 2025