510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K201876Substantially Equivalent

Soteria Bed Barrier

Trinity Guardion, Inc., Batesville IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K201876 is the FDA 510(k) clearance record for Soteria Bed Barrier, a class I device, cleared for Trinity Guardion on under FDA product code QTV (Mattress And Bed Deck Cover (Medical Purposes)). FDA's definition for product code QTV reads: "A mattress and bed deck cover for medical purposes is intended to provide a physical barrier between the patient and the mattress as well as all or parts of the bed deck or frame". FDA records list one 510(k) clearance for Trinity Guardion. As of , FDA records show no recalls naming K201876.

Clearance record

Decision date
Received
(786 days to decision)
Product code
QTV Mattress And Bed Deck Cover (Medical Purposes)
Regulation
21 CFR 880.6190
Device class
Class I
Review panel
General Hospital
Applicant
Trinity Guardion 4 S Park Ave. Suite 204, Batesville IN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QTV

Trailing 12 months

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

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