510(k) · Cleared
ClearedUSG 2000SA
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ultraguide, Ltd. · HHJ Locator, Intracorporeal Device, Ultrasonic, Obstetric-Gynecologic
Cleared on Oct 22, 2002 as substantially equivalent to K974432 (Ultraguide, Ltd., 1998) after a 25-day review. Its family tree reaches back 2 generations to 1988. 2 of the 285 devices in its family, counting itself, have a Class I recall. 280 later devices descend from it.
- Decided
- Oct 22, 2002
- Review
- 25 days
- Class
- Class II
- Product code
- HHJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K882383 (1988). 4 ancestors in all. 280 later devices descend from it, 2 citing it directly. 2 of the 285 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK882383 Maggi Series Ultra. Needle, Biopsy/Catheter GuidesCIVCO Medical Instruments Co., Inc. · 1988
- 1 generation backK974432 Ultraguide 1000Ultraguide, Ltd. · 1998
- This deviceK023227 USG 2000SAUltraguide, Ltd. · 2002
- Descendant · cites it directly · 278 of its ownK053610 AbarisTraxtal Technologies, Inc. · 2006 · Recalled
- Descendant · 2 generations on · 222 of its ownK121498 PercunavPhilips Health Care · 2012
- Descendant · 3 generations on · 211 of its ownK132304 Epiq Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2013 · Recalled
- Descendant · 4 generations on · 100 of its ownK160807 EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound…Philips Ultrasound, Inc. · 2016 · Recalled
- Descendant · 4 generations on · 87 of its ownK133833 Nuvis Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2014 · Recalled
Showing 5 of 280 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 280 · See all- K053610AbarisTraxtal Technologies, Inc. · 2006 · cites it directly278descendants
- K121498PercunavPhilips Health Care · 2012 · 2 generations on222descendants
- K132304Epiq Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2013 · 3 generations on211descendants
- K160807EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System, Affiniti 50…Philips Ultrasound, Inc. · 2016 · 4 generations on100descendants
- K133833Nuvis Diagnostic Ultrasound SystemPhilips Ultrasound, Inc. · 2014 · 4 generations on87descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K882383 | Maggi Series Ultra. Needle, Biopsy/Catheter Guides | CIVCO Medical Instruments Co., Inc. | 1988 | — |
| −1 | K974432 | Ultraguide 1000 | Ultraguide, Ltd. | 1998 | — |
| 0 (this device) | K023227 | USG 2000SA | Ultraguide, Ltd. | 2002 | — |
| +1 | K053610 | Abaris | Traxtal Technologies, Inc. | 2006 | 3 |
| +2 | K121498 | Percunav | Philips Health Care | 2012 | — |
| +3 | K132304 | Epiq Diagnostic Ultrasound System | Philips Ultrasound, Inc. | 2013 | 36 |
| +4 | K160807 | EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System… | Philips Ultrasound, Inc. | 2016 | 33 |
| +4 | K133833 | Nuvis Diagnostic Ultrasound System | Philips Ultrasound, Inc. | 2014 | 3 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 4 | 0 |
| 2014 | 8 | 0 |
| 2015 | 16 | 0 |
| 2016 | 16 | 0 |
| 2017 | 30 | 0 |
| 2018 | 19 | 0 |
| 2019 | 16 | 0 |
| 2020 | 27 | 0 |
| 2021 | 24 | 0 |
| 2022 | 23 | 0 |
| 2023 | 18 | 0 |
| 2024 | 19 | 0 |
| 2025 | 28 | 2 |
| 2026 | 22 | 0 |
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.
2 devices in this family have a Class I recall. 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 |
|---|---|---|---|
| * | K974432 | Ultraguide 1000Summary page 1…er ultrasonic imaging. C. Classification Name: Locator, Intracorporeal Device, Ultrasonic 111. Legally-marketed predicate devices. A. UltraGuide 1000, IC974432 IV. Description The UltraGuide USG 2000sa provides visual enhancement of the interventional needle by overlaying the im… | 1998 |
What descends from it? (280)
See all 2802 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
What does this lineage say?
- The line of descent spans 14 years and passes through 2 companies; a new generation was cleared every 9.2 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K053610 (Traxtal Technologies, Inc., 2006) has gone furthest, with 278 descendants of its own.
- 5 other devices also cite its predicate K974432.
How does its category compare?
All HHJ devicesHHJ Locator, Intracorporeal Device, Ultrasonic, Obstetric-Gynecologic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HHJ
FDA has decided no HHJ device since 2007.
Median 510(k) review, days · HHJ
Too few HHJ 510(k)s in any year since 2007 to give a median.
Recalls per year · HHJ
No recall names HHJ since 2007.
Adverse event reports per year · HHJ
No MAUDE report names HHJ since 2007.
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 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The UltraGuide USG 2000sa system is indicated for enhancing the ultrasonic image of an interventional needle or needle-like rigid device, such as a biopsy needle or an aspiration needle, and for predicting its future path. The enhancement and prediction are presented on a computer monitor screen which also shows the image of a B-scan (or similar display) of a medical ultrasound imaging system.
The device is intended to be used in clinical applications and for anatomical structures where ultrasound is currently used for visualizing such procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023227 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023227: USG 2000SA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023227
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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