510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K813497Substantially Equivalent

Rhythm Wheel

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

K813497 is the FDA 510(k) clearance record for RHYTHM WHEEL, cleared for Tropical Enterprises, Inc. on under FDA product code LHD (Device, Fertility Diagnostic, Proceptive). FDA records list one 510(k) clearance for Tropical Enterprises, Inc. As of , FDA records show no recalls naming K813497.

Clearance record

Decision date
Received
(140 days to decision)
Product code
LHD Device, Fertility Diagnostic, Proceptive
Device class
Unclassified
Review panel
Unknown
Applicant
Tropical Enterprises, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code LHD

Trailing 12 months

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

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