510(k) Report

510(k) · Cleared

Cleared

Squeeze-Ease Mammography Cushion

K031574510(k) TraditionalCleared Aug 4, 200376-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

S & S X-Ray Products, Inc. · IZH System, X-Ray, Mammographic

Cleared on Aug 4, 2003 as substantially equivalent to K003795 (Biolucent, Inc., 2001) after a 76-day review. Its family tree reaches back 1 generation to 2001.

Decided
Aug 4, 2003
Review
76 days
Class
Class II
Product code
IZH
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K003795 (2001). No later device cites it as a predicate yet.

K003795 · Biolucent Mammography Cushion · Biolucent, Inc. · 2001200020022004
K003795 · Biolucent Mammography Cushion · Biolucent, Inc. · 20010
  1. Root · 1 generation backK003795 Biolucent Mammography CushionBiolucent, Inc. · 2001
  2. This deviceK031574 Squeeze-Ease Mammography CushionS & S X-Ray Products, Inc. · 2003
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K003795Biolucent Mammography CushionBiolucent, Inc.2001—
0 (this device)K031574Squeeze-Ease Mammography CushionS & S X-Ray Products, Inc.2003—
FIG. 1 — Lineage of K031574, 2001–2003Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K202294 Affirm Contrast Biopsyscore 1.0 · 4 generations · no Class I recall
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K003795Biolucent Mammography Cushion
Summary page 1
…ate Summary Prepared: May 16,2003 2. Name of the Device: The Squeeze-EaseTMMammography Cushion 3. Predicate Device information: K#003795, Biolucent Mammography Cushion, Biolucent, Inc., Aliso Viejo, CA 4. Device Description: The Squeeze-EaseTMMammogr…
Biolucent, Inc.2001—

Also cleared against K003795: 1 other device →

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.
  • 1 other device also cites its predicate K003795.

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.

FDA decisions per year · IZH

1in 2021

2007: 32008: 12010: 22011: 12012: 22013: 22015: 12016: 32019: 12020: 12021: 1
2007high 3 (2007) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IZH

64in 2016

2007: 30 days median2016: 64 days median
2007high 64 (2016) · low 30 (2007)2026

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

Recalls per year · IZH

2in 2008

2008: 2
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

2007: 112008: 52009: 142010: 72011: 52012: 182013: 92014: 72015: 82016: 92017: 122018: 252019: 392020: 72021: 92022: 42023: 82024: 52025: 15
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007330011
20081—25
20090—014
20102—07
20111—05
20122—018
20132—09
20140—07
20151—08
201636409
20170—012
20180—025
20191—039
20201—07
20211—09
20220—04
20230—08
20240—05
20250—015
20260—0—

What is it indicated for?

The Squeeze-EaseTM Mammography Cushion provides padding for patient comfort during x-ray visualization of the breast.

Indications for use as stated in the FDA summary.

Also cleared against K003795

1 other device cites the same predicate.

  • K062141Mammopad Radiolucent CushionBiolucent, Inc. · 2006

More from S & S X-Ray Products, Inc.

4 FDA decisions under this applicant name. See the company

  • K944040Planet Thermoplastic Immobilization SystemS & S X-Ray Products, Inc. · 1995
  • K883317DCD-1 (Digital Contour Detect-Radiat Therapy) SystS & S X-Ray Products, Inc. · 1989
  • K850614Sand S MB12 Mammography Moving Grid BuckyS & S X-Ray Products, Inc. · 1985

Recent decisions in IZH

The IZH category page

  • K203509Smart FinderIms Giotto S.P.A. · 2021
  • K202294Affirm Contrast BiopsyHologic, Inc. · 2020
  • K191495Biopsy PositionerFujifilm Corporation · 2019
  • K161575Affirm Lateral Arm Upright Biopsy AccessoryHologic · 20161 recall
  • K161920Comfort CoverPrecision Dynamics Corporation · 2016

https://510kreport.com/device/K031574 · printed Nov 6, 2026

Cite this page

510(k) Report. “K031574: Squeeze-Ease Mammography Cushion.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031574

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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