510(k) · Cleared
ClearedSmartneedle Vascular Access System, Modification
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Peripheral Systems Group · ITX Transducer, Ultrasonic, Diagnostic
Cleared on Jun 10, 1994 after a 123-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.
- Decided
- Jun 10, 1994
- Review
- 123 days
- Class
- Class II
- Product code
- ITX
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK940804 Smartneedle Vascular Access System, ModificationPeripheral Systems Group · 1994
- Descendant · cites it directly · 2 of its ownK963989 P.D. Access (Percutaneous Doppler) Vascular Access DeviceCardiovascular Dynamics, Inc. · 1997
- Descendant · cites it directly · 1 of its ownK973713 22 Gauge P.D. Access Vascular Access Device (Catheter/Needle…Cardiovascular Dynamics, Inc. · 1998
- Descendant · 2 generations on · 0 of its ownK090743 Yield Mini Doppler SystemBroncus Technologies, Inc. · 2009
Most influential descendants
Showing 3 of 3 · See all- K963989P.D. Access (Percutaneous Doppler) Vascular Access DeviceCardiovascular Dynamics, Inc. · 1997 · cites it directly2descendants
- K97371322 Gauge P.D. Access Vascular Access Device (Catheter/Needle Assembly), 24 Gauge P.D.…Cardiovascular Dynamics, Inc. · 1998 · cites it directly1descendant
- K090743Yield Mini Doppler SystemBroncus Technologies, Inc. · 2009 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K940804 | Smartneedle Vascular Access System, Modification | Peripheral Systems Group | 1994 | — |
| +1 | K963989 | P.D. Access (Percutaneous Doppler) Vascular Access Device | Cardiovascular Dynamics, Inc. | 1997 | — |
| +1 | K973713 | 22 Gauge P.D. Access Vascular Access Device (Catheter/Needle Assembly), 24… | Cardiovascular Dynamics, Inc. | 1998 | — |
| +2 | K090743 | Yield Mini Doppler System | Broncus Technologies, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2009 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (3)
2 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?
- Of its descendants, K963989 (Cardiovascular Dynamics, Inc., 1997) has gone furthest, with 2 descendants of its own.
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 | — |
https://510kreport.com/device/K940804 · printed Nov 3, 2026
Cite this page
510(k) Report. “K940804: Smartneedle Vascular Access System, Modification.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K940804
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026