510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K791892Substantially Equivalent

Tape-a-Trace

Instromedix, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K791892 is the FDA 510(k) clearance record for TAPE-A-TRACE, a class II device, cleared for Instromedix, Inc. on under FDA product code DXM (Densitometer). FDA records list 33 510(k) clearances for Instromedix, Inc., from to . As of , FDA records show no recalls naming K791892.

Clearance record

Decision date
Received
(41 days to decision)
Product code
DXM Densitometer
Regulation
21 CFR 870.1450
Device class
Class II
Review panel
Cardiovascular
Applicant
Instromedix, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code DXM

Trailing 12 months

FDA records hold no clearances under product code DXM in the trailing twelve months.

FDA records show no clearances under product code DXM in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DXM, 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 20260
October 20260