510(k) · Cleared

Cleared

Parallax Tracer Radiopaque Particles

K991893510(k) TraditionalCleared Aug 13, 199971-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

Parallax Medical, Inc. · MYU Accessory, Barium Sulfate, Methyl Methacrylate For Cranioplasty

Cleared on Aug 13, 1999 as substantially equivalent to K873689 (Dentsply Intl., 1987) after a 71-day review. Its family tree reaches back 1 generation to 1987. 2 later devices descend from it.

Decided: Aug 13, 1999
Review: 71 days
Class: Class II
Product code: MYU
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K873689 (1987). 2 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK873689 Cranioplastic, Acrylic Cranioplasty MaterialDentsply Intl. · 1987
This deviceK991893 Parallax Tracer Radiopaque ParticlesParallax Medical, Inc. · 1999
Descendant · cites it directly · 1 of its ownK023445 Tracers Bone Cement OpacifierParallax Medical, Inc. · 2003
Descendant · 2 generations on · 0 of its ownK033230 Tracers TA Bone Cement Opacifier, Model TCR-TAParallax Medical, Inc. · 2003

Most influential descendants

Showing 2 of 2 · See all

K023445Tracers Bone Cement OpacifierParallax Medical, Inc. · 2003 · cites it directly1descendant
K033230Tracers TA Bone Cement Opacifier, Model TCR-TAParallax Medical, Inc. · 2003 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K873689	Cranioplastic, Acrylic Cranioplasty Material	Dentsply Intl.	1987	—
0 (this device)	K991893	Parallax Tracer Radiopaque Particles	Parallax Medical, Inc.	1999	—
+1	K023445	Tracers Bone Cement Opacifier	Parallax Medical, Inc.	2003	—
+2	K033230	Tracers TA Bone Cement Opacifier, Model TCR-TA	Parallax Medical, Inc.	2003	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	2	0

FIG. 1 — Lineage of K991893, 1987–2003Source: 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 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.

Type	Number	Device	Applicant	Decided	Recalls
*	K873689	Cranioplastic, Acrylic Cranioplasty Material Our OCR of the scanned summary read K873698, FDA’s number for Sterilized Dental Bit Packaging (Florida Diamond Instruments Corp.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Codman Cranioplastic™, Acrylic Cranioplasty Material”.	Dentsply Intl.	1987	—

Also cleared against K873689: 9 other devices →

What descends from it? (2)

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

Number	Device	Applicant	Decided	Descendants
K023445	Tracers Bone Cement Opacifier	Parallax Medical, Inc.	2003	1

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, K023445 (Parallax Medical, Inc., 2003) has gone furthest, with 1 descendant of its own.
9 other devices also cite its predicate K873689.

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

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

What is it indicated for?

Parallax™ Tracer Radiopaque Particles are intended for use as an additive to Codman Cranioplastic™ (Type 1 — Slow Set) to provide radiopacity for imaging purposes.

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/K991893 · printed Nov 4, 2026

Cite this page

510(k) Report. “K991893: Parallax Tracer Radiopaque Particles.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991893

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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