510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K843869Substantially Equivalent

Tranquility

Principle Business Ent., Dunbridge OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K843869 is the FDA 510(k) clearance record for TRANQUILITY, a class I device, cleared for Principle Business Ent. on under FDA product code EYQ (Garment, Protective, For Incontinence). FDA records list 3 510(k) clearances for Principle Business Ent., from to . As of , FDA records show no recalls naming K843869.

Clearance record

Decision date
Received
(45 days to decision)
Product code
EYQ Garment, Protective, For Incontinence
Regulation
21 CFR 876.5920
Device class
Class I
Review panel
Gastroenterology, Urology
Applicant
Principle Business Ent. Pine Lake Industrial Pk., Dunbridge OH
Third party review
No

Clearances, product code EYQ

Trailing 12 months

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

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