510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K062104Substantially Equivalent

Talking Trach

Engineered Medical Systems, LLC, Bonita Springs FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K062104 is the FDA 510(k) clearance record for TALKING TRACH, a class II device, cleared for Engineered Medical Systems, Inc. on under FDA product code BTO (Tube, Tracheostomy (W/Wo Connector)). FDA records list 25 510(k) clearances for Engineered Medical Systems, Inc., from to . As of , FDA records show no recalls naming K062104.

Clearance record

Decision date
Received
(270 days to decision)
Product code
BTO Tube, Tracheostomy (W/Wo Connector)
Regulation
21 CFR 868.5800
Device class
Class II
Review panel
Anesthesiology
Applicant
Engineered Medical Systems, Inc. 3460 Pt.e Creek, Bonita Springs 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