510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K884015Substantially Equivalent

Premier Decannulation Stopper

Premier Dental, Norristown PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K884015 is the FDA 510(k) clearance record for PREMIER DECANNULATION STOPPER, a class II device, cleared for Premier Dental on under FDA product code BTO (Tube, Tracheostomy (W/Wo Connector)). FDA records list one 510(k) clearance for Premier Dental. As of , FDA records show no recalls naming K884015.

Clearance record

Decision date
Received
(42 days to decision)
Product code
BTO Tube, Tracheostomy (W/Wo Connector)
Regulation
21 CFR 868.5800
Device class
Class II
Review panel
Anesthesiology
Applicant
Premier Dental Romano Dr., Norristown PA
Third party review
No

Clearances, product code BTO

Trailing 12 months
1 clearance under product code BTO in the twelve months to October 2026, September 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code BTO, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20261
October 20260