Product code BTT: 510(k) clearances and predicates
Product code BTT covers Laboratorios Biogalenic Sterile Water for Inhalation, USP. FDA lists 222 clearances under this code in the 510(k) index. This page summarizes recent clearance volume and names recent clearances by K number so you can pick predicates faster.
Clearance volume
222 clearances on file under product code BTT. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 3 |
| 2023 | 7 |
| 2024 | 7 |
| 2025 | 4 |
| 2026 so far | 4 |
Recent clearances
Newest BTT clearances in the FDA index, with applicant and decision date:
- K262268, Optiflow Oxygen Kit (AA484J), applicant Fisher and Paykel Healthcare Limited, decided 2026-08-27. FDA record
- K254078, HVT 2.0, applicant Vapotherm, Inc., decided 2026-04-13. FDA record
- K251448, FL-10000U Respiratory Humidifier, applicant Flexicare Medical Limited., decided 2026-01-16. FDA record
- K251419, Laboratorios Biogalenic Sterile Water for Inhalation, USP, applicant Laboratorios Biogalenic S.A. DE C.V., decided 2026-01-14. FDA record
- K253479, Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J), applicant Fisher & Paykel Healthcare, Ltd., decided 2025-12-19. FDA record
- K250312, Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus and Soft Plus Cannula Extra Small, applicant Medline Industries, LP, decided 2025-07-02. FDA record
- K251611, Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT944); Optiflow+ Nasal Cannula - Large (OPT946); Optiflow+ Nasal Cannula Small (MYOPT9SMALL); Optiflow+ Nasal Cannula Medium (MYOPT9MEDIUM); Optiflow+ Nasal Cannula Large (MYOPT9LARGE), applicant Fisher & Paykel Healthcare, Ltd., decided 2025-06-25. FDA record
- K242717, Laboratorios Biogalenic Sterile Water for Inhalation, USP, applicant Laboratorios Biogalenic S.A. DE C.V., decided 2025-01-30. FDA record
What this means for a regulatory watcher
Volume tells you how deep the predicate pool is. A code with steady yearly counts gives you many candidate predicates, which helps when one predicate has a recall or design gap. A code with a sharp recent rise means reviewers are seeing more of this device type, so substantial equivalence arguments need to track the newest cleared devices, not five year old ones. Related device names in recent clearances include Optiflow Oxygen Kit (AA484J), HVT 2.0. Watch new BTT clearances as they post: each one is a possible predicate for your submission and a possible competitor worth reading.
FAQ
What is FDA product code BTT?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent BTT clearances include Laboratorios Biogalenic Sterile Water for Inhalation, USP.
How many 510(k) clearances use product code BTT?
222 at the time this page was generated, from openFDA records.
How do I find a predicate device under BTT?
Start with the recent K numbers listed above, then run the free predicate search to check substantial equivalence text and review history.
How do I track new BTT clearances?
Get 510(k) alerts filtered to this product code and read each new clearance as it posts.
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.