Product code BZD: 510(k) clearances and predicates
Product code BZD covers Altis Full Face Mask. FDA lists 462 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
462 clearances on file under product code BZD. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 4 |
| 2023 | 5 |
| 2024 | 10 |
| 2025 | 7 |
| 2026 so far | 9 |
Recent clearances
Newest BZD clearances in the FDA index, with applicant and decision date:
- K261262, Altis Full Face Mask, applicant Respironics, Inc., decided 2026-09-25. FDA record
- K253044, RXiBreeze PAP System (RXiBreeze 20C), applicant Resvent Medical Technology Co., Ltd., decided 2026-07-23. FDA record
- K253553, Orion, applicant Resmed Corp, decided 2026-06-04. FDA record
- K254104, ResScan Essentials, applicant Resmed Corp, decided 2026-05-27. FDA record
- K251920, Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face Mask, applicant Dcstar, Inc., decided 2026-05-21. FDA record
- K253166, F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S), applicant BMC Medical Co., Ltd., decided 2026-04-29. FDA record
- K252338, MySleepDash, applicant Somnetics International, Inc. (Dba Transcend Inc), decided 2026-04-17. FDA record
- K251847, Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented Mask, applicant Sleepnet Corporation, decided 2026-01-15. 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 RXiBreeze PAP System (RXiBreeze 20C), Orion. Watch new BZD 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 BZD?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent BZD clearances include Altis Full Face Mask.
How many 510(k) clearances use product code BZD?
462 at the time this page was generated, from openFDA records.
How do I find a predicate device under BZD?
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 BZD clearances?
Get 510(k) alerts filtered to this product code and read each new clearance as it posts.
Get this for BZD, every week.
$49/month. Unlimited codes, one seat covers every client. Cancel anytime.
7-day free trial on the monthly plan. Card required, pay nothing for 7 days. 7-day money-back guarantee. Secure checkout via Stripe.
Not ready? Get one free BZD brief
Tell us where to send it. No card required.
You are on the list.
We will email your free BZD brief shortly. BZD is already in your watchlist draft. Want the ongoing watch instead of one brief? See the 7-day free trial.
Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.