510(k) · Cleared
Recalled · Class II · 2020Klarity Vacuum Bag, Klarity Mold Cushion
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Klarity Medical Products, LLC · IYE Accelerator, Linear, Medical
Cleared on Nov 1, 2013 as substantially equivalent to K040773 (Bionix Development Corp., 2004) and 1 other predicate after a 114-day review. Its family tree reaches back 2 generations to 1990. 1 later device descends from it. It has been recalled once.
- Decided
- Nov 1, 2013
- Review
- 114 days
- Class
- Class II
- Product code
- IYE
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K895697 (1990). 9 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK895697 Vac Fix (R) SystemS&S Par Scientific · 1990
- 1 generation backK040773 Pelvis Bellyboard Plus Patient Positioning SystemBionix Development Corp. · 2004
- This deviceK132124 Klarity Vacuum Bag, Klarity Mold CushionKlarity Medical Products, LLC · 2013
- Descendant · cites it directly · 0 of its ownK162265 CushionCast Moldable CushionsIzi Medical Products, LLC · 2016
Most influential descendants
Showing 1 of 1 · See all- K162265CushionCast Moldable CushionsIzi Medical Products, LLC · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K895697 | Vac Fix (R) System | S&S Par Scientific | 1990 | — |
| −1 | K040773 | Pelvis Bellyboard Plus Patient Positioning System | Bionix Development Corp. | 2004 | — |
| 0 (this device) | K132124 | Klarity Vacuum Bag, Klarity Mold Cushion | Klarity Medical Products, LLC | 2013 | — |
| +1 | K162265 | CushionCast Moldable Cushions | Izi Medical Products, LLC | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
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 IYE? 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 IYE device
- #1 K252977 Halcyon, Ethos Radiotherapy System (5.0)score 18.8 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K040773 | Pelvis Bellyboard Plus Patient Positioning SystemSummary page 1…classified as Class 11 by FDA and was given marketing clearance and assigned document control number K040773. Intended Use: The Klarity vacuum cushions are designed for the positioning and… | 2004 |
| * | K982624 | Moldcare Head & Neck Cushion, Model # MT-Acl-14242Summary page 3…classified as Class 11 by FDA and was given marketing clearance and assigned document control number K982624. Intended Use: The Klarity Mold Cushions are designed for the positioning and… | 1998 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K162265 | CushionCast Moldable Cushions | 2016 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 31, 2020 | Class II | Z-2881-2020 | Component design/selection | Vacuum bags potentially may not hold their vacuum adequately for needed patient treatment times. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 3 companies; a new generation was cleared every 14.2 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K162265 (Izi Medical Products, LLC, 2016) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K040773.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · IYE
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYE
170in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYE
101in 2025
MAUDE reports naming product code IYE, 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 | 23 | 44 | 78 | 155 |
| 2008 | 14 | 69 | 49 | 114 |
| 2009 | 20 | 63 | 22 | 174 |
| 2010 | 23 | 74 | 27 | 246 |
| 2011 | 11 | 94 | 73 | 280 |
| 2012 | 28 | 106 | 20 | 128 |
| 2013 | 18 | 88 | 11 | 96 |
| 2014 | 20 | 100 | 14 | 124 |
| 2015 | 20 | 108 | 8 | 100 |
| 2016 | 21 | 97 | 7 | 97 |
| 2017 | 23 | 94 | 7 | 125 |
| 2018 | 21 | 58 | 7 | 85 |
| 2019 | 19 | 83 | 2 | 91 |
| 2020 | 20 | 67 | 4 | 74 |
| 2021 | 19 | 86 | 5 | 68 |
| 2022 | 12 | 172 | 3 | 66 |
| 2023 | 18 | 129 | 7 | 128 |
| 2024 | 9 | 239 | 1 | 81 |
| 2025 | 12 | 170 | 1 | 101 |
| 2026 | 14 | 120 | 4 | — |
What is it indicated for?
To be used by trained medical professionals for the stable support and positioning of patients
undergoing external beam radiation therapy treatment in a clinic or hospital setting.
In particular, these items provide the stable positioning of patients in various positions, chosen to
facilitate the most accurate treatment of tumors.
Patients are those that have been diagnosed and are undergoing treatment for cancerous tumors.
Treatment is supervised and administered by licensed doctors and therapists trained in the
application of radiation therapy treatments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132124 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132124: Klarity Vacuum Bag, Klarity Mold Cushion.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132124
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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