510(k) · Cleared
ClearedSite-Rite Needle Guide Kits and Probe Cover Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bard Access Systems, Inc. · ITX Transducer, Ultrasonic, Diagnostic
Cleared on Oct 19, 2004 as substantially equivalent to K931403 (Dymax Corp, 1993) and 1 other predicate after a 40-day review. Its family tree reaches back 2 generations to 1985. 12 later devices descend from it.
- Decided
- Oct 19, 2004
- Review
- 40 days
- Class
- Class II
- Product code
- ITX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K844472 (1985). 3 ancestors in all. 12 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK844472 Civco Scan DrapeCIVCO Medical Instruments Co., Inc. · 1985
- 1 generation backK970889 Ultrasound Transducer DrapeProtek Medical Products, Inc. · 1997
- This deviceK042445 Site-Rite Needle Guide Kits and Probe Cover KitBard Access Systems, Inc. · 2004
- Descendant · cites it directly · 8 of its ownK120882 Site Rite Prevue Ultrasound System and Pinpoint Needle GuideBard Access Systems, Inc. · 2012
- Descendant · 2 generations on · 6 of its ownK152554 Site-Rite 8 Ultrasound System, Site-Rite 8 Ultrasound System with…C.R. Bard, Inc. · 2015 · Recalled
- Descendant · 3 generations on · 4 of its ownK182281 Site~Rite 8 Ultrasound System with Cue Needle Tracking System and…C. R. Bard · 2018
- Descendant · 4 generations on · 2 of its ownK211193 BD Prevue II Peripheral Vascular Vascular Access SystemBard Access Systems, Inc. (C.R. Bard, Inc.) · 2021
- Descendant · cites it directly · 2 of its ownK171348 Pinpoint GT Needle Guide KitsC.R. Bard, Inc. · 2017
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K120882Site Rite Prevue Ultrasound System and Pinpoint Needle GuideBard Access Systems, Inc. · 2012 · cites it directly8descendants
- K152554Site-Rite 8 Ultrasound System, Site-Rite 8 Ultrasound System with Pinpoint GT TechnologyC.R. Bard, Inc. · 2015 · 2 generations on6descendants
- K182281Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle TechC. R. Bard · 2018 · 3 generations on4descendants
- K211193BD Prevue II Peripheral Vascular Vascular Access SystemBard Access Systems, Inc. (C.R. Bard, Inc.) · 2021 · 4 generations on2descendants
- K171348Pinpoint GT Needle Guide KitsC.R. Bard, Inc. · 2017 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K844472 | Civco Scan Drape | CIVCO Medical Instruments Co., Inc. | 1985 | — |
| −1 | K970889 | Ultrasound Transducer Drape | Protek Medical Products, Inc. | 1997 | — |
| 0 (this device) | K042445 | Site-Rite Needle Guide Kits and Probe Cover Kit | Bard Access Systems, Inc. | 2004 | — |
| +1 | K120882 | Site Rite Prevue Ultrasound System and Pinpoint Needle Guide | Bard Access Systems, Inc. | 2012 | — |
| +2 | K152554 | Site-Rite 8 Ultrasound System, Site-Rite 8 Ultrasound System with Pinpoint GT… | C.R. Bard, Inc. | 2015 | 1 |
| +3 | K182281 | Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT… | C. R. Bard | 2018 | — |
| +4 | K211193 | BD Prevue II Peripheral Vascular Vascular Access System | Bard Access Systems, Inc. (C.R. Bard, Inc.) | 2021 | — |
| +1 | K171348 | Pinpoint GT Needle Guide Kits | C.R. Bard, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 1 | 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? (2)
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 |
|---|---|---|---|
| * | K931403 | Siterite Needle Guide (Modified)Summary page 1…. LEGALLY MARKETED PREDICATE DEVICES The Site-Rite Needle Guide Kits and Probe Cover Kit are substantially equivalent to the Site-Rite Needle Guide (K931403) and the Protek Medical Products, Inc. Ultrasound Transducer Drape Kit. (K970889). B. DEVICE DESCRIPTION Si… | 1993 |
| * | K970889 | Ultrasound Transducer DrapeSummary page 1…be Cover Kit are substantially equivalent to the Site-Rite Needle Guide (K931403) and the Protek Medical Products, Inc. Ultrasound Transducer Drape Kit. (K970889). B. DEVICE DESCRIPTION Site-Rite Needle Guide Kits - Single use sterile disposable needle guide kit availa… | 1997 |
What descends from it? (12)
See all 122 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)
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 19 years and passes through 3 companies; a new generation was cleared every 12.7 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K120882 (Bard Access Systems, Inc., 2012) has gone furthest, with 8 descendants of its own.
- 1 other device also cites its predicate K931403.
How does its category compare?
All ITX devicesITX Transducer, Ultrasonic, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Site-Rite Needle Guide Kits and Site-Rite Probe Cover Kits are intended to be used with Site-Rite Ultrasound Systems. The probe cover sheathes the transducer and isolates a site of surgical penetration from microbial and other contamination. The needle guide provides guidance for a needle to intersect an ultrasound beam at a fixed distance below the skin to assist the medical practitioner in placing the tip of a needle in a specific structure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042445 · printed Nov 4, 2026
Cite this page
510(k) Report. “K042445: Site-Rite Needle Guide Kits and Probe Cover Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042445
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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