Product code BTA: 510(k) clearances and predicates
Product code BTA covers powered suction pumps and aspirators. This page summarizes clearance volume, review timing from real FDA data, and recent clearances by K number so you can pick predicates faster.
Clearance volume
BTA is an active but narrow code. The trailing 24 month benchmark below uses 14 decisions. All time counts live in the FDA 510(k) index under regulation 878.4780.
Clearance timeline
Review timing over the trailing 24 months: median 119 days, 90th percentile 202 days (n=14 decisions).
What BTA covers
Product code BTA covers powered suction pumps and nasal aspirators (regulation 878.4780, General and Plastic Surgery). Recent BTA clearances include Nasal Aspirator (NS 13) and Nasal Aspirator (BC-021 through BC-026). Use the K numbers below as starting candidates and verify any predicate claim against the official 510(k) summary.
Recent clearances
Recent BTA clearances in the FDA index we track, with applicant and decision date:
- K241852, Nasal Aspirator (NS 13), applicant Avita Corporation, decided 2024-12-31. FDA record
- K242028, Nasal Aspirator (BC-021, BC-022, BC-023, BC-024, BC-025, BC-026), applicant Dongguanshi Yiyingmei Technology Co., Ltd., decided 2024-11-19. FDA record
What this means for a regulatory watcher
A code with steady but low volume gives you a short list of candidate predicates, which helps when one predicate has a recall or design gap. Track the newest cleared devices, not five year old ones. Watch new BTA clearances as they post: each one is a possible predicate for your submission and a possible competitor worth reading.
Run the free check for BTA to see the latest clearances without signing up.
FAQ
What is FDA product code BTA?
It is the three letter code FDA assigns to powered suction pump devices in the 510(k) index. Recent BTA clearances include nasal aspirators.
How long does a BTA 510(k) take?
Over the trailing 24 months to September 2026, median review was 119 days and the 90th percentile was 202 days (n=14). This is a planning reference from past clearances, not a prediction.
How do I find a predicate device under BTA?
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 BTA clearances?
Get 510(k) alerts filtered to this product code and read each new clearance as it posts. Or check BTA free first.
Get this for BTA, 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 BTA brief
Tell us where to send it. No card required.
You are on the list.
We will email your free BTA brief shortly. BTA 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). Benchmarks computed 2026-09-27. Not regulatory advice. Assume all results are unvalidated.
Last updated 2026-10-12.