510(k) · Cleared

Cleared

Dermatherapy, Model 22216

K061242510(k) TraditionalCleared Jan 25, 2007267-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 Jan 25, 2007 as substantially equivalent to K903382 (Allergy Control Products, Inc., 1990) after a 267-day review. Its family tree reaches back 1 generation to 1990. 1 later device descends from it.

Decided: Jan 25, 2007
Review: 267 days
Class: Class I
Product code: FMW
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K903382 (1990). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK903382 Allergy Control CoversAllergy Control Products, Inc. · 1990
This deviceK061242 Dermatherapy, Model 22216Precision Fabrics Group, Inc. · 2007
Descendant · cites it directly · 0 of its ownK152884 DermaTherapy Bed LinensPrecision Fabrics Group, Inc. · 2016

Most influential descendants

Showing 1 of 1 · See all

K152884DermaTherapy Bed LinensPrecision Fabrics Group, Inc. · 2016 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

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

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2016	1	0

FIG. 1 — Lineage of K061242, 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
*	K903382	Allergy Control Covers Summary page 1 …er for Medical Purposes (21 CFR 880.6190); Product Code FMW D.3 Substantial Equivalence Claimed to Predicate Devices Allergy Control Cover, K903382 D.4 Device Description The device that is the subject of this 510(k) premarket notification is generally described…	Allergy Control Products, Inc.	1990	—

Also cleared against K903382: 1 other device →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K152884	DermaTherapy Bed Linens	Precision Fabrics Group, Inc.	2016	0

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.
Of its descendants, K152884 (Precision Fabrics Group, Inc., 2016) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K903382.

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. 2007, 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?

Institutional Bedding (bed sheets and pillow cases) made with DermaTherapy TM fabrics is intended for use by patients in a hospital, healthcare or home setting who are susceptible to or may have mild atopic dermatitis.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K061242 · printed Nov 6, 2026

Cite this page

510(k) Report. “K061242: Dermatherapy, Model 22216.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061242

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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