510(k) · Cleared
ClearedStimuplex Onvision System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems Nederland B.V. · BSP Needle, Conduction, Anesthetic (W/Wo Introducer)
Cleared on May 27, 2020 as substantially equivalent to K121812 (Ultrasonix Medical Corporation, 2013) and 2 other predicates after a 225-day review. Its family tree reaches back 8 generations to 1994. 7 of the 68 devices in its family, counting itself, have a Class I recall.
- Decided
- May 27, 2020
- Review
- 225 days
- Class
- Class II
- Product code
- BSP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K911783 (1994). 67 ancestors in all, the oldest K801912 (1980). No later device cites it as a predicate yet. 7 of the 68 devices in this family, counting this one, have a Class I recall.
- Root · 8 generations backK911783 Allegro Viewing WandI.S.G. Technologies, Inc. · 1994
- 7 generations backK981998 Pediatric Instatrak SystemVisualization Technology, Inc. · 1998 · Recalled (Class I)
- 6 generations backK983529 Instatrak 3000Visualization Technology, Inc. · 1998 · Recalled (Class I)
- 5 generations backK994270 Instatrak 3000 System with Fluorotrak Module, Model IT3000Visualization Technology, Inc. · 2000 · Recalled (Class I)
- 4 generations backK053610 AbarisTraxtal Technologies, Inc. · 2006 · Recalled
- 3 generations backK121498 PercunavPhilips Health Care · 2012
- 2 generations backK132087 Percunav SystemPhilips Health Care · 2013
- 1 generation backK170716 PercuNav Image Fusion and Interventional NavigationPhilips Ultrasound, Inc. · 2017
- This deviceK192914 Stimuplex Onvision SystemPhilips Medical Systems Nederland B.V. · 2020
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K911783 | Allegro Viewing Wand | I.S.G. Technologies, Inc. | 1994 | — |
| −7 | K981998 | Pediatric Instatrak System | Visualization Technology, Inc. | 1998 | Class I |
| −6 | K983529 | Instatrak 3000 | Visualization Technology, Inc. | 1998 | Class I |
| −5 | K994270 | Instatrak 3000 System with Fluorotrak Module, Model IT3000 | Visualization Technology, Inc. | 2000 | Class I |
| −4 | K053610 | Abaris | Traxtal Technologies, Inc. | 2006 | 3 |
| −3 | K121498 | Percunav | Philips Health Care | 2012 | — |
| −2 | K132087 | Percunav System | Philips Health Care | 2013 | — |
| −1 | K170716 | PercuNav Image Fusion and Interventional Navigation | Philips Ultrasound, Inc. | 2017 | — |
| 0 (this device) | K192914 | Stimuplex Onvision System | Philips Medical Systems Nederland B.V. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 1 |
| 1983 | 1 | 0 |
| 1984 | 1 | 0 |
| 1988 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 1 |
| 1997 | 2 | 0 |
| 1998 | 7 | 1 |
| 1999 | 4 | 0 |
| 2000 | 7 | 0 |
| 2001 | 7 | 0 |
| 2002 | 9 | 0 |
| 2003 | 5 | 0 |
| 2004 | 2 | 1 |
| 2005 | 2 | 0 |
| 2007 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 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.
7 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 BSP device
- #1 K241954 SonoBlock; SonoBlock IIscore 11.0 · 1 generation · 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 |
|---|---|---|---|
| * | K121812 | SonixgpsSummary page 4…Product code IYO PREDICATE DEVICES: • Primary predicate device: SonixGPS Nerve Block Needle Kit, Ultrasonix Medical Corporation (K121812) • Additional predicate devices: o PercuNav Image Fusion and Interventional Navigation (K170716) o B.Bra… | 2013 |
| * | K170716 | PercuNav Image Fusion and Interventional NavigationSummary page 4…Block Needle Kit, Ultrasonix Medical Corporation (K121812) • Additional predicate devices: o PercuNav Image Fusion and Interventional Navigation (K170716) o B.Braun Stimuplex® D Plus Insulated Echogenic Needle(K100241) DEVICE DESCRIPTION: The proposed Stimuplex® On… | 2017 |
| * | K100241 | Contiplex D Continuous Nerve Block Set, Model 331687, 331686, 331685, 331680Summary page 4…Additional predicate devices: o PercuNav Image Fusion and Interventional Navigation (K170716) o B.Braun Stimuplex® D Plus Insulated Echogenic Needle(K100241) DEVICE DESCRIPTION: The proposed Stimuplex® Onvision® system is an add-on device to the Philips Xperius ultrasoun… | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (7 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.
- K040050Instatrak System with Multiple Dataset Navigation, Model IT3500Ge Medical Systems Navigation and Visualization IN · 2004 · 5 generations back · ◆ in the 2004 ancestors bar of FIG. 11 Class I recall
- K994270Instatrak 3000 System with Fluorotrak Module, Model IT3000Visualization Technology, Inc. · 2000 · 5 generations back · ◆ on the line of descent in FIG. 12 Class I recalls
- K983529Instatrak 3000Visualization Technology, Inc. · 1998 · 5 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K982994Skull Base Instatrak SystemVisualization Technology, Inc. · 1998 · 5 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K981998Pediatric Instatrak SystemVisualization Technology, Inc. · 1998 · 5 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K960330InstatrakVisualization Technology, Inc. · 1996 · 5 generations back · ◆ in the 1996 ancestors bar of FIG. 11 Class I recall
- K801912Arrow Positive Placement Con/Epidural anArrow Intl., Inc. · 1980 · 6 generations back · ◆ in the 1980 ancestors bar of FIG. 11 Class I recall
Nearest 5 of 7; all are on the web page.
What does this lineage say?
- The line of descent spans 26 years and passes through 6 companies; a new generation was cleared every 3.7 years on median.
- 22 of the 67 ancestors have a recall of any class; 7 have a Class I recall.
How does its category compare?
All BSP devicesBSP Needle, Conduction, Anesthetic (W/Wo Introducer): FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · BSP
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BSP
170in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BSP
1in 2020
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · BSP
86in 2025
MAUDE reports naming product code BSP, 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 | 3 | 189 | 0 | 26 |
| 2008 | 8 | 127 | 0 | 24 |
| 2009 | 5 | 97 | 0 | 30 |
| 2010 | 3 | 79 | 0 | 49 |
| 2011 | 3 | 114 | 0 | 33 |
| 2012 | 3 | 148 | 0 | 20 |
| 2013 | 2 | — | 0 | 32 |
| 2014 | 2 | — | 0 | 41 |
| 2015 | 2 | — | 0 | 38 |
| 2016 | 6 | 268 | 1 | 152 |
| 2017 | 4 | 186 | 0 | 34 |
| 2018 | 8 | 241 | 0 | 69 |
| 2019 | 2 | — | 1 | 86 |
| 2020 | 3 | 269 | 1 | 78 |
| 2021 | 3 | 265 | 0 | 52 |
| 2022 | 2 | — | 0 | 84 |
| 2023 | 0 | — | 0 | 75 |
| 2024 | 3 | 70 | 0 | 66 |
| 2025 | 4 | 170 | 0 | 86 |
| 2026 | 0 | — | 1 (1) | — |
What is it indicated for?
The Stimuplex® Onvision® system is intended for clinically trained physicians to perform regional anesthesia and pain therapy to target peripheral nerves by tracking the B.Braun Stimuplex® Onvision® needle tip position by overlaying a circle at the given location using the Philips Xperius® Ultrasound and Onvision® System. The B.Braun Stimuplex® Onvision® needle is used to inject local anesthesia or analgesic to the targeted nerve bundle to induce regional anesthesia for surgical procedures. The Stimuplex® HNS 12 can also be used for nerve stimulation when connected to the system cable.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192914 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192914: Stimuplex Onvision System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192914
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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