510(k) · Cleared
Recalled · Class II · 2017Vascular Positioning System TM (VPS TM System) Stylet
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vasonova, Inc. · OBJ Catheter, Ultrasound, Intravascular
Cleared on Feb 18, 2011 as substantially equivalent to K081625 (Vasonova, Inc., 2008) and 1 other predicate after a 107-day review. Its family tree reaches back 9 generations to 2000. 5 of the 43 devices in its family, counting itself, have a Class I recall. 10 later devices descend from it. It has been recalled 4 times.
- Decided
- Feb 18, 2011
- Review
- 107 days
- Class
- Class II
- Product code
- OBJ
- Recalls
- 4
- Predicates
- 2
Its longest line of descent runs back 9 generations to K001901 (2000). 32 ancestors in all, the oldest K823434 (1982). 10 later devices descend from it, 5 citing it directly. 5 of the 43 devices in this family, counting this one, have a Class I recall.
- Root · 9 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 5 generations between
- 3 generations backK081625 Flowpicc StyletVasonova, Inc. · 2008
- 2 generations backK091324 Sherlock 3CG Tip Positioning System, Sherlock 3CG Tip Positioning…C.R. Bard, Inc. · 2009 · Recalled
- 1 generation backK093775 Evguide Tip Location SystemRomedex International Srl · 2010
- This deviceK103255 Vascular Positioning System TM (VPS TM System) StyletVasonova, Inc. · 2011
- Descendant · cites it directly · 3 of its ownK132133 CG+ Arrow Jacc Powered by Arrow VPS StyletArrow International (Subsidiary of Teleflex Inc.) · 2013 · Recalled (Class I)
- Descendant · cites it directly · 3 of its ownK123759 CG+ Arrow Picc Powered by Arrow VPS StyletArrow International, Inc. (Subsidiary of Teleflex · 2013
- Descendant · 2 generations on · 2 of its ownK130876 CG+ Arrow Picc Powered by Arrow VPS StyletArrow International, Inc. · 2013 · Recalled (Class I)
- Descendant · cites it directly · 2 of its ownK122545 CG+ Arrow Picc Powered by Arrow VPS StyletArrow International (Subsidiary of Teleflex Inc.) · 2012 · Recalled (Class I)
- Descendant · 2 generations on · 1 of its ownK153423 CG+ Arrow JACC powered by Arrow VPS Stylet, CG+ Arrow JACCArrow International, Inc. (Subsidiary of Teleflex, Inc.) · 2016 · Recalled (Class I)
Show all 9 generations
- Root · 9 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 8 generations backK012902 Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly…C.R. Bard, Inc. · 2001
- 7 generations backK031129 Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc. · 2003
- 6 generations backK034019 Poly Per-Q-Cath Picc CathetersC.R. Bard, Inc. · 2004 · Recalled
- 5 generations backK060341 Sherlock Tip Location System (TLS)C.R. Bard, Inc. · 2006
- 4 generations backK063240 Sherlock TLS Stylet, Sherlock TLS DetectorC.R. Bard, Inc. · 2006 · Recalled
- 3 generations backK081625 Flowpicc StyletVasonova, Inc. · 2008
- 2 generations backK091324 Sherlock 3CG Tip Positioning System, Sherlock 3CG Tip Positioning…C.R. Bard, Inc. · 2009 · Recalled
- 1 generation backK093775 Evguide Tip Location SystemRomedex International Srl · 2010
- This deviceK103255 Vascular Positioning System TM (VPS TM System) StyletVasonova, Inc. · 2011
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K122545 CG+ Arrow Picc Powered by Arrow VPS Styletcites it directly · 2012
- K132133 CG+ Arrow Jacc Powered by Arrow VPS Styletcites it directly · 2013
- K130876 CG+ Arrow Picc Powered by Arrow VPS Stylet2 generations on · 2013
- K153423 CG+ Arrow JACC powered by Arrow VPS Stylet, CG+…2 generations on · 2016
Most influential descendants
Showing 5 of 10 · See all- K132133CG+ Arrow Jacc Powered by Arrow VPS StyletArrow International (Subsidiary of Teleflex Inc.) · 2013 · cites it directly3descendants
- K123759CG+ Arrow Picc Powered by Arrow VPS StyletArrow International, Inc. (Subsidiary of Teleflex · 2013 · cites it directly3descendants
- K130876CG+ Arrow Picc Powered by Arrow VPS StyletArrow International, Inc. · 2013 · 2 generations on2descendants
- K122545CG+ Arrow Picc Powered by Arrow VPS StyletArrow International (Subsidiary of Teleflex Inc.) · 2012 · cites it directly2descendants
- K153423CG+ Arrow JACC powered by Arrow VPS Stylet, CG+ Arrow JACCArrow International, Inc. (Subsidiary of Teleflex, Inc.) · 2016 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K001901 | Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline… | C.R. Bard, Inc. | 2000 | 2 |
| −8 | K012902 | Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath… | C.R. Bard, Inc. | 2001 | — |
| −7 | K031129 | Poly Per-Q-Cath Picc Catheters; Poly Radpicc | C.R. Bard, Inc. | 2003 | — |
| −6 | K034019 | Poly Per-Q-Cath Picc Catheters | C.R. Bard, Inc. | 2004 | 1 |
| −5 | K060341 | Sherlock Tip Location System (TLS) | C.R. Bard, Inc. | 2006 | — |
| −4 | K063240 | Sherlock TLS Stylet, Sherlock TLS Detector | C.R. Bard, Inc. | 2006 | 18 |
| −3 | K081625 | Flowpicc Stylet | Vasonova, Inc. | 2008 | — |
| −2 | K091324 | Sherlock 3CG Tip Positioning System, Sherlock 3CG Tip Positioning System Stylet | C.R. Bard, Inc. | 2009 | 11 |
| −1 | K093775 | Evguide Tip Location System | Romedex International Srl | 2010 | — |
| 0 (this device) | K103255 | Vascular Positioning System TM (VPS TM System) Stylet | Vasonova, Inc. | 2011 | — |
| +1 | K132133 | CG+ Arrow Jacc Powered by Arrow VPS Stylet | Arrow International (Subsidiary of Teleflex Inc.) | 2013 | Class I |
| +1 | K123759 | CG+ Arrow Picc Powered by Arrow VPS Stylet | Arrow International, Inc. (Subsidiary of Teleflex | 2013 | — |
| +2 | K130876 | CG+ Arrow Picc Powered by Arrow VPS Stylet | Arrow International, Inc. | 2013 | Class I |
| +1 | K122545 | CG+ Arrow Picc Powered by Arrow VPS Stylet | Arrow International (Subsidiary of Teleflex Inc.) | 2012 | Class I |
| +2 | K153423 | CG+ Arrow JACC powered by Arrow VPS Stylet, CG+ Arrow JACC | Arrow International, Inc. (Subsidiary of Teleflex, Inc.) | 2016 | Class I |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1984 | 1 | 0 |
| 1986 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 1 |
| 2013 | 3 | 2 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 2 |
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.
5 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 OBJ device
- #1 K242893 VERAFEYE System VERAFEYE Imaging Catheter &…score 23.8 · 30 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 |
|---|---|---|---|
| * | K081625 | Flowpicc StyletSummary page 1…vascular Regulation 21 CFR §870.1200 Product Code(s) OBJ Legally marketed FIowPICC Stylet (K081625) device(s) to which Sapiens Tm Tip Location System (TLS) (K093775) equivalence is claimed Reason for… | 2008 |
| * | K093775 | Evguide Tip Location SystemSummary page 1…OBJ Legally marketed FIowPICC Stylet (K081625) device(s) to which Sapiens Tm Tip Location System (TLS) (K093775) equivalence is claimed Reason for 510(k) Expanded labeling submissionII Device description… | 2010 |
What descends from it? (10)
5 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K132133 | CG+ Arrow Jacc Powered by Arrow VPS Stylet Class I | 2013 | 3 |
| K123759 | CG+ Arrow Picc Powered by Arrow VPS Stylet | 2013 | 3 |
| K122545 | CG+ Arrow Picc Powered by Arrow VPS Stylet Class I | 2012 | 2 |
| K141618 | Arrow VPS Stylet Plus and CG+ Arrow Picc Powered by Arrow VPS Stylet Plus | 2014 | 1 |
| K121941 | Arrow Picc Powered by Arrow VPS Stylet | 2012 | 0 |
Has anything in its family been recalled? (5 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 1, 2017 | Class II | Z-0179-2018 | Mixed-up of materials/components | There is a possibility that the finished good kits may contain 5 Fr peel-away sheaths instead of the required 4 Fr peel-away sheaths. |
| Apr 28, 2017 | Class II | Z-2170-2017 | Unknown/Undetermined by firm | Arrow International is notifying each customer who received the affected that product that the kits do not contain important information regarding the 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing. |
| Jul 30, 2015 | Class II | Z-2462-2015 | Unknown/Undetermined by firm | the catheter peel-away component hub tabs may prematurely detach. One injury reported. |
| Jul 30, 2015 | Class II | Z-2489-2015 | Under Investigation by firm | saline leakage from unsecured connections between the Touhy Borst adaptor and the hub of the catheter. No injuries reported. |
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.
- K122545CG+ Arrow Picc Powered by Arrow VPS StyletArrow International (Subsidiary of Teleflex Inc.) · 2012 · Cites it directly · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
- K132133CG+ Arrow Jacc Powered by Arrow VPS StyletArrow International (Subsidiary of Teleflex Inc.) · 2013 · Cites it directly · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K130876CG+ Arrow Picc Powered by Arrow VPS StyletArrow International, Inc. · 2013 · 2 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K153423CG+ Arrow JACC powered by Arrow VPS Stylet, CG+ Arrow JACCArrow International, Inc. (Subsidiary of Teleflex, Inc.) · 2016 · 2 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
- K153487CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUSArrow International, Inc. (Subsidiary of Teleflex, Inc.) · 2016 · 2 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 11 months on median.
- 7 of the 32 ancestors have a recall of any class.
- Of its descendants, K132133 (Arrow International (Subsidiary of Teleflex Inc.), 2013) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K081625.
How does its category compare?
All OBJ devicesOBJ Catheter, Ultrasound, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · OBJ
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OBJ
35in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OBJ
2in 2020
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · OBJ
791in 2025
MAUDE reports naming product code OBJ, 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 | 74 | 0 | 0 |
| 2008 | 6 | 100 | 0 | 6 |
| 2009 | 3 | 108 | 0 | 22 |
| 2010 | 1 | — | 0 | 39 |
| 2011 | 4 | 109 | 0 | 47 |
| 2012 | 3 | 136 | 0 | 53 |
| 2013 | 4 | 96 | 0 | 328 |
| 2014 | 3 | 30 | 0 | 609 |
| 2015 | 4 | 131 | 2 | 401 |
| 2016 | 4 | 94 | 0 | 515 |
| 2017 | 6 | 45 | 2 | 524 |
| 2018 | 2 | — | 2 | 542 |
| 2019 | 1 | — | 0 | 237 |
| 2020 | 4 | 135 | 2 | 288 |
| 2021 | 3 | 29 | 0 | 353 |
| 2022 | 3 | 63 | 0 | 473 |
| 2023 | 3 | 63 | 0 | 697 |
| 2024 | 3 | 131 | 0 | 1,154 |
| 2025 | 7 | 35 | 0 | 791 |
| 2026 | 4 | 81 | 1 (1) | — |
What is it indicated for?
The VPS Stylet and Console are indicated for guidance and tip positioning for central venous catheters. The Stylet provides stiffness for use in placement of the catheter, intravascular capability for EG detection and recording and intravascular ultrasound for catheter guiding and positioning. The VPS Stylet, when used with the VPS Console, provides real-time catheter tip location information by using the patient's physiological (cardiac electrical.…
Read the full statement (192 words)
The VPS Stylet and Console are indicated for guidance and tip positioning for central venous catheters. The Stylet provides stiffness for use in placement of the catheter, intravascular capability for EG detection and recording and intravascular ultrasound for catheter guiding and positioning. The VPS Stylet, when used with the VPS Console, provides real-time catheter tip location information by using the patient's physiological (cardiac electrical. activity and blood flow) information. When the VPS System guidance indicator shows a blue bullseye, the catheter tip is in the desired location. The VPS System is indicated for use as an alternative method to fluoroscopy or chest x-ray for central venous catheter tip placement confirmation in adult patients.
Limiting but not contraindicated situations for this technique are in patients where alterations of cardiac rhythm change the presentation of the P-wave as in atrial fibrillation, atrial flutter, severe tachycardia and pacemaker-driven rhythm, and in central venous catheterization procedures performed through femoral or saphenous vein access which change the presentation of the P-wave. In such patients, who are easily identifiable prior to central venous catheter insertion, the use of an additional method is required to confirm catheter tip location.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103255 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103255: Vascular Positioning System TM (VPS TM System) Stylet.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103255
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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