Cleared Traditional

K201876 - Soteria Bed Barrier (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

K201876 · Trinity Guardion · General & Plastic Surgery device
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Sep 2022
Decision
786d
Days
Class 1
Risk

K201876 is an FDA 510(k) clearance for the Soteria Bed Barrier. Classified as Mattress And Bed Deck Cover (medical Purposes) (product code QTV), Class I - General Controls.

Submitted by Trinity Guardion (Batesville, US). The FDA issued a Cleared decision on September 1, 2022 after a review of 786 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 880.6190 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

View all Trinity Guardion devices

Submission Details

510(k) Number K201876 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 2020
Decision Date September 01, 2022
Days to Decision 786 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
672d slower than avg
Panel avg: 114d · This submission: 786d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code QTV Mattress And Bed Deck Cover (medical Purposes)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6190
Definition 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.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.