510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K013728Substantially Equivalent

Trach Vox

Engineered Medical Systems, LLC, Mccordsville IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K013728 is the FDA 510(k) clearance record for TRACH VOX, a class II device, cleared for Engineered Medical Systems on under FDA product code JOH (Tube Tracheostomy And Tube Cuff). FDA records list 25 510(k) clearances for Engineered Medical Systems, from to . As of , FDA records show no recalls naming K013728.

Clearance record

Decision date
Received
(263 days to decision)
Product code
JOH Tube Tracheostomy And Tube Cuff
Regulation
21 CFR 868.5800
Device class
Class II
Review panel
Anesthesiology
Applicant
Engineered Medical Systems 6329 W. Waterview Ct., Mccordsville IN
510(k) summary
Summary
Third party review
No

Clearances, product code JOH

Trailing 12 months
1 clearance under product code JOH in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code JOH, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260