510(k) · Cleared
ClearedSoteria Bed Barrier
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Trinity Guardion · QTV Mattress And Bed Deck Cover (Medical Purposes)
Cleared on Sep 1, 2022 as substantially equivalent to K780033 (Chase Mfg. Co., 1978) after a 786-day review. Its family tree reaches back 1 generation to 1978.
- Decided
- Sep 1, 2022
- Review
- 786 days
- Class
- Class I
- Product code
- QTV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K780033 (1978). No later device cites it as a predicate yet.
- Root · 1 generation backK780033 Mattresses, Conductive & CoversChase Mfg. Co. · 1978
- This deviceK201876 Soteria Bed BarrierTrinity Guardion · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K780033 | Mattresses, Conductive & Covers | Chase Mfg. Co. | 1978 | — |
| 0 (this device) | K201876 | Soteria Bed Barrier | Trinity Guardion | 2022 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QTV? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K780033 | Mattresses, Conductive & CoversSummary page 4…urposes Classification: Class 1 (21 CFR 880.6190) Product Code: QTV III. Predicate Device Predicate Device: Chase Mfg. Co Mattress Cover, K780033 Reference Devices: Welmed Surgical Drape, K070432, DAS Medical, DAS Medical Equipment Drapes, K121436 IV. Device Descriptio… | 1978 |
| † | K070432 | General Surgery Drapes | 2007 |
| † | K121436 | Das Medical Equipment Drapes | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All QTV devicesQTV Mattress And Bed Deck Cover (Medical Purposes): FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · QTV
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · QTV
Too few QTV 510(k)s in any year since 2007 to give a median.
Recalls per year · QTV
No recall names QTV since 2007.
Adverse event reports per year · QTV
1in 2025
MAUDE reports naming product code QTV, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Soteria Bed Barrier is a cover for compatible bed decks and mattresses to provide a protective physical barrier between the equipment and the patient. The device is intended to prevent soiling of bed decks and mattresses, helping to reduce contamination during use.
The Soteria Bed Barriers are classified as level 3 per AAMI Standard PB70 Liquid barrier performance and classification of protective apparel and drapes intended for use in healthcare facilities.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K201876 · printed Nov 3, 2026
Cite this page
510(k) Report. “K201876: Soteria Bed Barrier.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K201876
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026