510(k) Report

510(k) · Cleared

Cleared

LV Liberty Vision Model 1 90 Yttrium Brachytherapy Source

K163572510(k) TraditionalCleared Mar 15, 201786-day reviewClass II21 CFR 892.5730

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

Lv Liberty Vision Corp. · KXK Source, Brachytherapy, Radionuclide

Cleared on Mar 15, 2017 as substantially equivalent to K142701 (Salutaris Medical Devices, Inc., 2014) after an 86-day review. Its family tree reaches back 1 generation to 2014. 1 later device descends from it.

Decided
Mar 15, 2017
Review
86 days
Class
Class II
Product code
KXK
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K142701 (2014). 1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2020: 1 descendant clearedK142701 · SMD Sr90-1 Radionuclide Brachytherapy Source · Salutaris Medical Devices, Inc. · 20142010201520202025
Descendants, by generation 1 generation forward: 1 descendant K142701 · SMD Sr90-1 Radionuclide Brachytherapy Source · Salutaris Medical Devices, Inc. · 20140
  1. Root · 1 generation backK142701 SMD Sr90-1 Radionuclide Brachytherapy SourceSalutaris Medical Devices, Inc. · 2014
  2. This deviceK163572 LV Liberty Vision Model 1 90 Yttrium Brachytherapy SourceLv Liberty Vision Corp. · 2017
  3. Descendant · cites it directly · 0 of its ownK193602 LV Liberty Vision Model 1 90Yttrium Brachytherapy SourceLv Liberty Vision Corporation · 2020

Most influential descendants

Showing 1 of 1 · See all
  • K193602LV Liberty Vision Model 1 90Yttrium Brachytherapy SourceLv Liberty Vision Corporation · 2020 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K142701SMD Sr90-1 Radionuclide Brachytherapy SourceSalutaris Medical Devices, Inc.2014—
0 (this device)K163572LV Liberty Vision Model 1 90 Yttrium Brachytherapy SourceLv Liberty Vision Corp.2017—
+1K193602LV Liberty Vision Model 1 90Yttrium Brachytherapy SourceLv Liberty Vision Corporation2020—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202010
FIG. 1 — Lineage of K163572, 2014–2020Source: 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 KXK? 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 KXK device

  1. #1 K242818 IsoSpherescore 10.9 · 5 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin 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.

TypeNumberDeviceApplicantDecidedRecalls
*K142701SMD Sr90-1 Radionuclide Brachytherapy Source
Summary page 4
…ytherapy Source (3) Legally Marketed Predicate Device: Salutaris Medical Devices, Inc. Smd Sr90-1 Radionuclide Brachytherapy Source, cleared under 510(k) number K142701 dated 24 April 2015 (4) Description of LV Liberty Vision Model 1 90Yttrium Brachytherapy Source: LV Liberty Vision Model 1 9…
Salutaris Medical Devices, Inc.2014—

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K193602LV Liberty Vision Model 1 90Yttrium Brachytherapy SourceLv Liberty Vision Corporation20200

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, K193602 (Lv Liberty Vision Corporation, 2020) has gone furthest, with 0 descendants of its own.

How does its category compare?

All KXK devices

KXK Source, Brachytherapy, Radionuclide: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.

FDA decisions per year · KXK

2in 2025

2007: 52008: 12009: 72010: 12011: 52012: 32013: 32014: 82015: 22016: 42017: 22018: 12019: 22020: 32022: 12023: 12025: 2
2007high 8 (2014) · low 0 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KXK

158in 2020

2007: 42 days median2009: 63 days median2011: 94 days median2012: 109 days median2013: 127 days median2014: 96 days median2016: 49 days median2020: 158 days median
2007high 158 (2020) · low 42 (2007)2026

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

Recalls per year · KXK

1in 2016

2008: 12011: 12012: 12016: 1
2007high 1 (2008) · low 0 (2007)2026

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

Adverse event reports per year · KXK

7in 2025

2007: 92008: 152009: 102011: 352012: 42013: 292014: 132015: 62016: 402017: 412018: 282019: 102020: 152021: 622022: 262023: 92024: 152025: 7
2007high 62 (2021) · low 0 (2010)2025

MAUDE reports naming product code KXK, 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
200754209
20081—115
2009763010
20101—00
2011594135
2012310914
20133127029
2014896013
20152—06
2016449140
20172—041
20181—028
20192—010
20203158015
20210—062
20221—026
20231—09
20240—015
20252—07
20260—0—

What is it indicated for?

LV Liberty Vision Model 1 90 Yttrium Brachytherapy Source with individual activity up to 20 mCi (740 MBq), is indicated for episcleral brachytherapy of tumors and benign growths. The Model 1 source is intended for use within a manual brachytherapy system.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Cite this page

510(k) Report. “K163572: LV Liberty Vision Model 1 90 Yttrium Brachytherapy Source.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K163572

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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