510(k) · Cleared
ClearedUltraguide 1000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ultraguide, Ltd. · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Feb 9, 1998 as substantially equivalent to K926351 (Echocath, Inc., 1993) and 2 other predicates after a 77-day review. Its family tree reaches back 1 generation to 1988. 2 of the 362 devices in its family, counting itself, have a Class I recall. 358 later devices descend from it.
- Decided
- Feb 9, 1998
- Review
- 77 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K882383 (1988). 3 ancestors in all. 358 later devices descend from it, 6 citing it directly. 2 of the 362 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK882383 Maggi Series Ultra. Needle, Biopsy/Catheter GuidesCIVCO Medical Instruments Co., Inc. · 1988
- This deviceK974432 Ultraguide 1000Ultraguide, Ltd. · 1998
- Descendant · cites it directly · 280 of its ownK023227 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
Showing 5 of 358 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 358 · See all- K023227USG 2000SAUltraguide, Ltd. · 2002 · cites it directly280descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K882383 | Maggi Series Ultra. Needle, Biopsy/Catheter Guides | CIVCO Medical Instruments Co., Inc. | 1988 | — |
| 0 (this device) | K974432 | Ultraguide 1000 | Ultraguide, Ltd. | 1998 | — |
| +1 | 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 |
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 |
|---|---|---|
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 5 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 6 | 0 |
| 2013 | 5 | 0 |
| 2014 | 15 | 0 |
| 2015 | 20 | 0 |
| 2016 | 20 | 0 |
| 2017 | 36 | 0 |
| 2018 | 24 | 0 |
| 2019 | 20 | 0 |
| 2020 | 34 | 0 |
| 2021 | 29 | 0 |
| 2022 | 28 | 0 |
| 2023 | 22 | 0 |
| 2024 | 25 | 0 |
| 2025 | 35 | 2 |
| 2026 | 26 | 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.
Top candidate predicates for a new IYO device
- #1 K243937 Accuro 3Sscore 20.5 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K926351 | Colormark (TM) Visualization SystemSummary page 1…der ultrasonic imaging. C. Classification Name: Locator, Intracorporeal Device, Ultrasonic III. Legally-marketed predicate devices. A. ColorMark Visualization System, K 926351, EchoCath Inc. B. EchoTip Needles, Cook Manufacturing Co. C. Regulus Stereotactic system, K935456 D. Civco Needle Guide, K882383… | 1993 |
| * | K935456 | Regulus Measurement UnitSummary page 1…gally-marketed predicate devices. A. ColorMark Visualization System, K 926351, EchoCath Inc. B. EchoTip Needles, Cook Manufacturing Co. C. Regulus Stereotactic system, K935456 D. Civco Needle Guide, K882383 IV. Description The UltraGuide 1000 provides visual enhancement of the interventional needle by… | 1995 |
| * | K882383 | Maggi Series Ultra. Needle, Biopsy/Catheter GuidesSummary page 1…s. A. ColorMark Visualization System, K 926351, EchoCath Inc. B. EchoTip Needles, Cook Manufacturing Co. C. Regulus Stereotactic system, K935456 D. Civco Needle Guide, K882383 IV. Description The UltraGuide 1000 provides visual enhancement of the interventional needle by overlaying the image of the ins… | 1988 |
| * | — | EchoTip Needles Named without a submission number |
What descends from it? (358)
See all 3586 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?
How does its category compare?
All IYO devicesIYO System, Imaging, Pulsed Echo, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IYO
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYO
171in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYO
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYO
485in 2025
MAUDE reports naming product code IYO, 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 | 20 | 17 | 4 | 39 |
| 2008 | 14 | 36 | 5 | 20 |
| 2009 | 13 | 79 | 9 | 27 |
| 2010 | 15 | 113 | 8 | 20 |
| 2011 | 11 | 69 | 0 | 58 |
| 2012 | 15 | 68 | 2 | 78 |
| 2013 | 17 | 50 | 3 | 436 |
| 2014 | 14 | 63 | 2 | 304 |
| 2015 | 19 | 46 | 1 | 268 |
| 2016 | 10 | 36 | 0 | 254 |
| 2017 | 19 | 72 | 0 | 238 |
| 2018 | 14 | 56 | 1 | 368 |
| 2019 | 13 | 59 | 1 | 537 |
| 2020 | 11 | 57 | 0 | 498 |
| 2021 | 15 | 64 | 11 | 617 |
| 2022 | 5 | 190 | 1 | 511 |
| 2023 | 11 | 177 | 0 | 527 |
| 2024 | 10 | 220 | 0 | 640 |
| 2025 | 7 | 171 | 0 | 485 |
| 2026 | 10 | 139 | 1 | — |
What is it indicated for?
The UltraGuide 1000 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 wused in <clinical applications and for anatomical structures where ultrasound is currently used for visualizing such procedures.
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/K974432 · printed Nov 4, 2026
Cite this page
510(k) Report. “K974432: Ultraguide 1000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K974432
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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