510(k) · Cleared
ClearedCRX World Shunt
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Phoenix Biomedical Corp. · JXG Shunt, Central Nervous System And Components
Cleared on Apr 1, 1999 as substantially equivalent to K951925 (Dicomit Imaging Systems Corp., 1995) and 2 other predicates after a 64-day review. Its family tree reaches back 2 generations to 1994.
- Decided
- Apr 1, 1999
- Review
- 64 days
- Class
- Class II
- Product code
- JXG
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K930768 (1994). 4 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K930768 | Orion Diagnostic Ultrasound System | GE Medical Systems | 1994 | — |
| −1 | K964617 | GE Logiq 700 Diagnostic Ultrasound System | GE Medical Systems | 1997 | — |
| 0 (this device) | K990256 | CRX World Shunt | Phoenix Biomedical Corp. | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JXG? 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 JXG device
- #1 K243531 Codman Libertís Shunt Catheter with Bactiseal…score 11.9 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K951925 | DicomitSummary page 1…ame: Ultrasonic Pulsed Echo Imaging System (3) ldentification of predicate devices: Manufacturer Device 510(k) Number Dicomit Imaging Systems Corp. Dicom Image Manager K951925 Advanced Technology Labs ATL HDI 3000/5000 Ultrasound systems K961459 General Electric Medical Systems GE LOGIQ 700 Ultrasound sy… | 1995 |
| * | K961459 | Level 10 HdiSummary page 1…icate devices: Manufacturer Device 510(k) Number Dicomit Imaging Systems Corp. Dicom Image Manager K951925 Advanced Technology Labs ATL HDI 3000/5000 Ultrasound systems K961459 General Electric Medical Systems GE LOGIQ 700 Ultrasound system K964617 (4) Description of the device: The software changes des… | 1997 |
| * | K964617 | GE Logiq 700 Diagnostic Ultrasound SystemSummary page 1…s Corp. Dicom Image Manager K951925 Advanced Technology Labs ATL HDI 3000/5000 Ultrasound systems K961459 General Electric Medical Systems GE LOGIQ 700 Ultrasound system K964617 (4) Description of the device: The software changes described in this submission enable the DICOMIT Dicom Image Manager - with… | 1997 |
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?
- The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 3.6 years on median.
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate K951925.
How does its category compare?
All JXG devicesJXG Shunt, Central Nervous System And Components: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JXG
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JXG
255in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JXG
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JXG
1,198in 2025
MAUDE reports naming product code JXG, 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 | 3 | 184 | 0 | 649 |
| 2008 | 6 | 60 | 1 | 630 |
| 2009 | 5 | 106 | 30 | 629 |
| 2010 | 3 | 30 | 0 | 812 |
| 2011 | 7 | 136 | 5 | 787 |
| 2012 | 3 | 78 | 1 | 977 |
| 2013 | 3 | 108 | 14 | 1,004 |
| 2014 | 0 | — | 6 | 1,251 |
| 2015 | 6 | 276 | 0 | 984 |
| 2016 | 6 | 143 | 0 | 1,091 |
| 2017 | 7 | 90 | 1 | 1,335 |
| 2018 | 6 | 102 | 0 | 1,484 |
| 2019 | 4 | 101 | 0 | 1,295 |
| 2020 | 2 | — | 8 | 1,206 |
| 2021 | 1 | — | 0 | 1,467 |
| 2022 | 4 | 101 | 0 | 1,329 |
| 2023 | 5 | 134 | 2 | 1,221 |
| 2024 | 3 | 90 | 3 | 1,214 |
| 2025 | 8 | 255 | 0 | 1,198 |
| 2026 | 2 | — | 1 | — |
https://510kreport.com/device/K990256 · printed Nov 5, 2026
Cite this page
510(k) Report. “K990256: CRX World Shunt.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K990256
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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