510(k) · Cleared

Cleared

DermaTherapy Bed Linens

K152884510(k) TraditionalCleared Jun 20, 2016264-day reviewClass I21 CFR 880.6190

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Precision Fabrics Group, Inc. · FMW Cover, Mattress (Medical Purposes)

Cleared on Jun 20, 2016 as substantially equivalent to K061242 (Precision Fabrics Group, Inc., 2007) after a 264-day review. Its family tree reaches back 2 generations to 1990.

Decided: Jun 20, 2016
Review: 264 days
Class: Class I
Product code: FMW
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K903382 (1990). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK903382 Allergy Control CoversAllergy Control Products, Inc. · 1990
1 generation backK061242 Dermatherapy, Model 22216Precision Fabrics Group, Inc. · 2007
This deviceK152884 DermaTherapy Bed LinensPrecision Fabrics Group, Inc. · 2016

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K903382	Allergy Control Covers	Allergy Control Products, Inc.	1990	—
−1	K061242	Dermatherapy, Model 22216	Precision Fabrics Group, Inc.	2007	—
0 (this device)	K152884	DermaTherapy Bed Linens	Precision Fabrics Group, Inc.	2016	—

FIG. 1 — Lineage of K152884, 1990–2016Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 FMW? 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

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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	Applicant	Decided	Recalls
*	K061242	Dermatherapy, Model 22216 Summary page 4 …e: FMW Predicate Devices: Primary Predicate: Precision Fabrics Group’s Institutional Bedding made with DermaTherapy Fabrics (K061242) Indications for Use: Bed linens made with DermaTherapy fabrics are intended for use by patients 18 years of age and older in…	Precision Fabrics Group, Inc.	2007	—

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?

The line of descent spans 26 years and passes through 2 companies; a new generation was cleared every 16.2 years on median.
None of the 2 ancestors has a recall.

How does its category compare?

All FMW devices

FMW Cover, Mattress (Medical Purposes): FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.

FDA decisions per year · FMW

1in 2016

2007high 1 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FMW

Too few FMW 510(k)s in any year since 2007 to give a median.

Recalls per year · FMW

2in 2007

2007high 2 (2007) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FMW

2in 2025

2007high 32 (2013) · low 0 (2008)2025

MAUDE reports naming product code FMW, 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	1	—	2	1
2008	0	—	0	0
2009	0	—	0	0
2010	0	—	0	2
2011	0	—	0	19
2012	0	—	0	13
2013	0	—	0	32
2014	0	—	0	22
2015	0	—	0	1
2016	1	—	0	0
2017	0	—	0	4
2018	0	—	0	1
2019	0	—	0	4
2020	0	—	0	0
2021	0	—	0	0
2022	0	—	0	0
2023	0	—	0	3
2024	0	—	0	4
2025	0	—	0	2
2026	0	—	0	—

What is it indicated for?

Bed linens made with DermaTherapy® fabrics are intended for use by patients 18 years of age and older in hospital settings who are susceptible to pressure ulcers. The DermaTherapy Bed Linens help to reduce the likelihood of patients developing pressure ulcers by reducing moisture, friction and shear on the patient’s skin.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K152884 · printed Nov 6, 2026

Cite this page

510(k) Report. “K152884: DermaTherapy Bed Linens.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152884

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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