Cleared Traditional

K251419 - Laboratorios Biogalenic Sterile Water for Inhalation, USP (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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
113d slower than avg
Panel avg: 139d · This submission: 252d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 220
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
FL-10000U Respiratory Humidifier
K251448 · Flexicare Medical Limited. · Jan 2026
Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J)
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