510(k) · Cleared
Recalled · Class II · 2025Ultrasound General Purpose Guidance System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Civco Medical Instruments · ITX Transducer, Ultrasonic, Diagnostic
Cleared on Jan 19, 2010 as substantially equivalent to K882383 (CIVCO Medical Instruments Co., Inc., 1988) and 2 other predicates after a 49-day review. Its family tree reaches back 5 generations to 1985. 4 later devices descend from it. It has been recalled 7 times.
- Decided
- Jan 19, 2010
- Review
- 49 days
- Class
- Class II
- Product code
- ITX
- Recalls
- 7
- Predicates
- 3
Its longest line of descent runs back 5 generations to K850478 (1985). 8 ancestors in all. 4 later devices descend from it, 4 citing it directly.
- Root · 5 generations backK850478 PLUS 1Dymax Corp · 1985
- 4 generations backK993624 Site-Rite 3 Ultrasound SystemDymax Corp · 1999
- 3 generations backK032135 Site-Rite IV Ultrasound SystemDymax Corp · 2003
- 2 generations backK052517 Site-Rite 5 Ultrasound SystemC.R. Bard, Inc. · 2005
- 1 generation backK071204 Site-Rite 6 Ultrasound System, Model Site-Rite 6C.R. Bard, Inc. · 2007
- This deviceK093713 Ultrasound General Purpose Guidance SystemCivco Medical Instruments · 2010
- Descendant · cites it directly · 0 of its ownK260114 Align® Cover and Pad Guidance ToolCIVCO Medical Instruments Co., Inc. · 2026
- Descendant · cites it directly · 0 of its ownK262474 ND Needle Guidance SystemAccurate Access, LLC · 2026
- Descendant · cites it directly · 0 of its ownK171040 Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and…Koelis · 2017
- Descendant · cites it directly · 0 of its ownK111426 Euclid (TM) Tier 1-GW Access SystemHouston Medical Robotics · 2012
Most influential descendants
Showing 4 of 4 · See all- K260114Align® Cover and Pad Guidance ToolCIVCO Medical Instruments Co., Inc. · 2026 · cites it directly0descendants
- K262474ND Needle Guidance SystemAccurate Access, LLC · 2026 · cites it directly0descendants
- K171040Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and…Koelis · 2017 · cites it directly0descendants
- K111426Euclid (TM) Tier 1-GW Access SystemHouston Medical Robotics · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K850478 | PLUS 1 | Dymax Corp | 1985 | — |
| −4 | K993624 | Site-Rite 3 Ultrasound System | Dymax Corp | 1999 | — |
| −3 | K032135 | Site-Rite IV Ultrasound System | Dymax Corp | 2003 | — |
| −2 | K052517 | Site-Rite 5 Ultrasound System | C.R. Bard, Inc. | 2005 | — |
| −1 | K071204 | Site-Rite 6 Ultrasound System, Model Site-Rite 6 | C.R. Bard, Inc. | 2007 | — |
| 0 (this device) | K093713 | Ultrasound General Purpose Guidance System | Civco Medical Instruments | 2010 | — |
| +1 | K260114 | Align® Cover and Pad Guidance Tool | CIVCO Medical Instruments Co., Inc. | 2026 | — |
| +1 | K262474 | ND Needle Guidance System | Accurate Access, LLC | 2026 | — |
| +1 | K171040 | Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD… | Koelis | 2017 | — |
| +1 | K111426 | Euclid (TM) Tier 1-GW Access System | Houston Medical Robotics | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1988 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2017 | 1 | 0 |
| 2026 | 2 | 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.
Planning a device in ITX? 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 ITX device
- #1 K260114 Align® Cover and Pad Guidance Toolscore 13.6 · 6 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 |
|---|---|---|---|
| * | K882383 | Maggi Series Ultra. Needle, Biopsy/Catheter GuidesSummary page 2…Instruments claims the proposed devices to be substantially equivalent to the devices previously cleared by FDA in K882383,1 K071204 and K(030064. CIVCO claims this equivalence because the proposed… | 1988 |
| * | K071204 | Site-Rite 6 Ultrasound System, Model Site-Rite 6Summary page 2…and repeatability. Predicate Device: K(882383 - MAGGI SERIES ULTRA. NEEDLE, BIOPSY/CATHBET'ER GUIDES K071204 - SITE-RITE 6 ULTRASOUND SYSTEMv4 MODEL SITE-RITE 6 K(030064 - ROOK 25 NEE… | 2007 |
| * | K030064 | Ilook 25 Needle Guide Attachment and Bracket AssemblySummary page 2…BIOPSY/CATHBET'ER GUIDES K071204 - SITE-RITE 6 ULTRASOUND SYSTEMv4 MODEL SITE-RITE 6 K(030064 - ROOK 25 NEEDLE GUIDE ATITACHMENT AND BRACKET ASSEMBLY Substantial Equivalence: CIVCO Medical Ins… | 2003 |
What descends from it? (4)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 1, 2025 | Class II | Z-1892-2025 | Process design | During the attachment of the needle guide to the covered probe, the tight tolerance and fit of the needle guide can cause a pinhole breach in the transducer cover when latching the guide in place. |
| Feb 23, 2018 | Class II | Z-2888-2018 | Device Design | A cover failed leak testing during validation testing of new needle guides from a replacement tool. |
| Oct 21, 2015 | Class II | Z-0287-2016 | Process design | Sterility of the product cannot be assured. |
| Oct 21, 2015 | Class II | Z-0286-2016 | Process design | Sterility of the product cannot be assured. |
| Oct 21, 2015 | Class II | Z-0288-2016 | Process design | Sterility of the product cannot be assured. |
| Oct 21, 2015 | Class II | Z-0290-2016 | Process design | Sterility of the product cannot be assured. |
| Oct 21, 2015 | Class II | Z-0289-2016 | Process design | Sterility of the product cannot be assured. |
The 5 latest of 7 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 3 companies; a new generation was cleared every 2.7 years on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K260114 (CIVCO Medical Instruments Co., Inc., 2026) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K882383.
How does its category compare?
All ITX devicesITX Transducer, Ultrasonic, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · ITX
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ITX
126in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ITX
2in 2025
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · ITX
571in 2025
MAUDE reports naming product code ITX, 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 | 10 | 26 | 0 | 16 |
| 2008 | 12 | 73 | 4 | 39 |
| 2009 | 17 | 28 | 4 | 23 |
| 2010 | 10 | 42 | 4 | 30 |
| 2011 | 10 | 16 | 1 | 34 |
| 2012 | 7 | 25 | 1 | 29 |
| 2013 | 3 | 105 | 0 | 38 |
| 2014 | 4 | 41 | 1 | 43 |
| 2015 | 1 | — | 5 | 183 |
| 2016 | 4 | 151 | 0 | 269 |
| 2017 | 6 | 110 | 1 | 412 |
| 2018 | 2 | — | 15 | 130 |
| 2019 | 1 | — | 0 | 119 |
| 2020 | 3 | 120 | 3 | 116 |
| 2021 | 3 | 139 | 10 (10) | 146 |
| 2022 | 2 | — | 6 | 87 |
| 2023 | 6 | 213 | 1 | 138 |
| 2024 | 3 | 81 | 1 | 988 |
| 2025 | 4 | 126 | 2 | 571 |
| 2026 | 6 | 158 | 0 | — |
What is it indicated for?
The guidance system is intended for directing instruments such as catheters, electrodes and needles into a targeted anatomical location of a patient relative to the imaging instrument for percutaneous procedures. Prior to use healthcare workers should be trained in ultrasonography. The following models are included in this submission:
MODEL — INTENDED USE
Ultra-Pro WIIT Needle Guides
Ultra-Pro 3"h Needle Guides
AccuSITE Transverse Needle Guides
Infiniti Needle Guides
Multi-Pro 2000 Needle Guides
MAGGI HI Plus Needle Guides — The bracket and disposable guide provide physicians with a tool for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093713 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093713: Ultrasound General Purpose Guidance System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093713
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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