510(k) · Cleared

Cleared

Comfort Cover

K161920510(k) TraditionalCleared Jul 15, 20162-day reviewClass II21 CFR 892.1710

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

Precision Dynamics Corporation · IZH System, X-Ray, Mammographic

Cleared on Jul 15, 2016 as substantially equivalent to K073262 (Beekley Corp., 2008) after a 2-day review. Its family tree reaches back 3 generations to 2001.

Decided: Jul 15, 2016
Review: 2 days
Class: Class II
Product code: IZH
Recalls: None
Predicates: 1

Its longest line of descent runs back 3 generations to K003795 (2001). No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK003795 Biolucent Mammography CushionBiolucent, Inc. · 2001
2 generations backK062141 Mammopad Radiolucent CushionBiolucent, Inc. · 2006
1 generation backK073262 BELLABeekley Corp. · 2008 · Recalled
This deviceK161920 Comfort CoverPrecision Dynamics Corporation · 2016

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K003795	Biolucent Mammography Cushion	Biolucent, Inc.	2001	—
−2	K062141	Mammopad Radiolucent Cushion	Biolucent, Inc.	2006	—
−1	K073262	BELLA	Beekley Corp.	2008	1
0 (this device)	K161920	Comfort Cover	Precision Dynamics Corporation	2016	—

FIG. 1 — Lineage of K161920, 2001–2016Source: 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 IZH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new IZH device

#1 K202294 Affirm Contrast Biopsyscore 1.0 · 4 generations · no Class I recall

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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
*	K073262	BELLA Summary page 4 …mographic Regulatory Classification: Class II Regulation Number: 892.1710 Product Code: IZH (3) PREDICATE DEVICE K073262, Bella, Bella Blankets: Beekley Corporation Classification Name: System, X-ray, mammographic Regulatory Cl…	Beekley Corp.	2008	1

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 15 years and passes through 3 companies; a new generation was cleared every 5.6 years on median.
1 of the 3 ancestors has a recall of any class.

How does its category compare?

All IZH devices

IZH System, X-Ray, Mammographic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.

FDA decisions per year · IZH

1in 2021

2007high 3 (2007) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IZH

64in 2016

2007high 64 (2016) · low 30 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · IZH

2in 2008

2007high 2 (2008) · low 0 (2007)2026

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

Adverse event reports per year · IZH

15in 2025

2007high 39 (2019) · low 4 (2022)2025

MAUDE reports naming product code IZH, 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	3	30	0	11
2008	1	—	2	5
2009	0	—	0	14
2010	2	—	0	7
2011	1	—	0	5
2012	2	—	0	18
2013	2	—	0	9
2014	0	—	0	7
2015	1	—	0	8
2016	3	64	0	9
2017	0	—	0	12
2018	0	—	0	25
2019	1	—	0	39
2020	1	—	0	7
2021	1	—	0	9
2022	0	—	0	4
2023	0	—	0	8
2024	0	—	0	5
2025	0	—	0	15
2026	0	—	0	—

What is it indicated for?

The indications for use of the product is to remove the cold from the bucky by placing this sheet between patient’s breast and the image receptor plate allowing the patient to feel more comfortable and less cold without interfering with image quality.

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/K161920 · printed Nov 3, 2026

Cite this page

510(k) Report. “K161920: Comfort Cover.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K161920

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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