510(k) · Cleared
ClearedUltra ICE Plus 9 MHz IntraCardiac Echo Catheter (eDFU), Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (Paper DFU)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corporation · DXK Echocardiograph
Cleared on Feb 26, 2016 as substantially equivalent to K902245 (Boston Scientific Corp, 1990) after a 30-day review. Its family tree reaches back 1 generation to 1990.
- Decided
- Feb 26, 2016
- Review
- 30 days
- Class
- Class II
- Product code
- DXK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K902245 (1990). No later device cites it as a predicate yet.
- Root · 1 generation backK902245 Sonicath (TM) 9F, 12 MHZBoston Scientific Corp · 1990
- This deviceK160173 Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (eDFU), Ultra ICE…Boston Scientific Corporation · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K902245 | Sonicath (TM) 9F, 12 MHZ | Boston Scientific Corp | 1990 | — |
| 0 (this device) | K160173 | Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (eDFU), Ultra ICE Plus 9 MHz… | Boston Scientific Corporation | 2016 | — |
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 DXK? 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
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 | Decided |
|---|---|---|---|
| * | K902245 | Sonicath (TM) 9F, 12 MHZSummary page 4…) has been classified as Class II per 21 CFR 892.1570. Predicate Device Ultra ICE™ 9 MHz K902245 9-Oct-1990 IntraCardiac Echo Catheter Ultra ICE Plus is intended for use with Bosto… | 1990 |
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 K902245.
How does its category compare?
All DXK devicesDXK Echocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · DXK
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · DXK
Too few DXK 510(k)s in any year since 2007 to give a median.
Recalls per year · DXK
No recall names DXK since 2007.
Adverse event reports per year · DXK
1in 2024
MAUDE reports naming product code DXK, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 1 | — | 0 | 4 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Ultra ICE Plus rounded tip catheter is indicated for enhanced ultrasonic visualization of intracardiac structures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160173 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160173: Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (eDFU), Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (Paper DFU).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160173
Report an extraction error
Are you the manufacturer?
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