510(k) Report

510(k) · Cleared

Cleared

Vista Scientific Barium Sulfate, Model 3001-1

K024359510(k) AbbreviatedCleared Aug 8, 2003221-day reviewClass II21 CFR 882.5300

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

Vista Scientific, LLC · MYU Accessory, Barium Sulfate, Methyl Methacrylate For Cranioplasty

Cleared on Aug 8, 2003 as substantially equivalent to K002063 (Bryan Corp., 2000) after a 221-day review. Its family tree reaches back 1 generation to 2000.

Decided
Aug 8, 2003
Review
221 days
Class
Class II
Product code
MYU
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K002063 (2000). No later device cites it as a predicate yet.

K002063 · Biotrace, Model 1730 · Bryan Corp. · 2000200020022004
K002063 · Biotrace, Model 1730 · Bryan Corp. · 20000
  1. Root · 1 generation backK002063 Biotrace, Model 1730Bryan Corp. · 2000
  2. This deviceK024359 Vista Scientific Barium Sulfate, Model 3001-1Vista Scientific, LLC · 2003
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K002063Biotrace, Model 1730Bryan Corp.2000—
0 (this device)K024359Vista Scientific Barium Sulfate, Model 3001-1Vista Scientific, LLC2003—
FIG. 1 — Lineage of K024359, 2000–2003Source: 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 MYU? 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.

TypeNumberDeviceApplicantDecidedRecalls
*K002063Biotrace, Model 1730
Summary page 1
…Trade Name Vista Scientific AxioView Barium Sulfateru GenericKommon Name Barium Sulfate USP Predicate Device Biotrace@Bone Cement Radio-Opacifier (Bryan Corporation) (K002063) Action taken to comply with Section 514 of the Act No applicable mandatory performance standards or special controls exist for…
Bryan Corp.2000—

Also cleared against K002063: 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 K002063.

How does its category compare?

All MYU devices

MYU Accessory, Barium Sulfate, Methyl Methacrylate For Cranioplasty: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MYU

FDA has decided no MYU device since 2007.

Median 510(k) review, days · MYU

Too few MYU 510(k)s in any year since 2007 to give a median.

Recalls per year · MYU

No recall names MYU since 2007.

Adverse event reports per year · MYU

No MAUDE report names MYU since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

Vista Scientific Barium Sulfate™ is intended for use as an additive to Codman Cranioplastic™ (Type 1-Slow set) to provide radiopacity for imaging purposes.

Indications for use as stated in the FDA summary.

Also cleared against K002063

1 other device cites the same predicate.

  • K041105Macropore Hydrosorb Spine SystemMacropore Biosurgery, Inc. · 2004

Recent decisions in MYU

The MYU category page

  • K033230Tracers TA Bone Cement Opacifier, Model TCR-TAParallax Medical, Inc. · 2003
  • K032388Bone Cement Radio-OpacifierCardinalhealth · 2003
  • K023445Tracers Bone Cement OpacifierParallax Medical, Inc. · 2003
  • K002063Biotrace, Model 1730Bryan Corp. · 2000
  • K991893Parallax Tracer Radiopaque ParticlesParallax Medical, Inc. · 1999

https://510kreport.com/device/K024359 · printed Nov 3, 2026

Cite this page

510(k) Report. “K024359: Vista Scientific Barium Sulfate, Model 3001-1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K024359

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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