510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K101721Substantially Equivalent

Well Lead Tracheostomy Tube and Disposable Inner Cannula

Regulatory & Marketing Services, Inc., Appollo Beach FL / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K101721 is the FDA 510(k) clearance record for WELL LEAD TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA, a class II device, cleared for Regulatory and Marketing Services, Inc. on under FDA product code BTO (Tube, Tracheostomy (W/Wo Connector)). FDA records list 22 510(k) clearances for Regulatory and Marketing Services, Inc., from to . As of , FDA records show no recalls naming K101721.

Clearance record

Decision date
Received
(279 days to decision)
Product code
BTO Tube, Tracheostomy (W/Wo Connector)
Regulation
21 CFR 868.5800
Device class
Class II
Review panel
Anesthesiology
Applicant
Regulatory and Marketing Services, Inc. 962 Allegro Ln., Appollo Beach FL
510(k) summary
Summary PDF
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