510(k) · Cleared
Recalled · Class II · 2024Vascular Probe, Vascular Probe ES
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synovis Life Technologies, Inc. · DWP Dilator, Vessel, Surgical
Cleared on Apr 24, 2013 as substantially equivalent to K910682 (Bio-Vascular, Inc., 1991) after a 23-day review. Its family tree reaches back 1 generation to 1991. It has been recalled 2 times.
- Decided
- Apr 24, 2013
- Review
- 23 days
- Class
- Class II
- Product code
- DWP
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K910682 (1991). No later device cites it as a predicate yet.
- Root · 1 generation backK910682 Robicsek Probe/RetractorBio-Vascular, Inc. · 1991
- This deviceK130896 Vascular Probe, Vascular Probe ESSynovis Life Technologies, Inc. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K910682 | Robicsek Probe/Retractor | Bio-Vascular, Inc. | 1991 | — |
| 0 (this device) | K130896 | Vascular Probe, Vascular Probe ES | Synovis Life Technologies, Inc. | 2013 | — |
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 DWP? 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 DWP device
- #1 K220981 SUPERPLAST Double-Occluder, SUPERPLAST…score 5.8 · 3 generations · no Class I recall
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K910682 | Robicsek Probe/RetractorSummary page 1…P Predicate Device Synovis Life Technologies Inc. (previously doing business as Bio-Vascular, Inc.), Robicsek Probe/Retractor; 510(k) K(910682 Device Description The Vascular Probe is a sterile, single use, disposable device with a polyurethane coat… | 1991 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 22, 2024 | Class II | Z-1524-2024 | Under Investigation by firm | The Surgical Tools and Cardiovascular Specialty marketing brochures distributed for Flo-Rester Disposable Internal Vessel Occluder, Flo-Thru Intraluminal Shunt, and Vascular Probe Intravascular Probe contain inaccurate content that does… |
| Dec 6, 2023 | Class II | Z-0659-2024 | Under Investigation by firm | Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Instructions for Use (IFU) or Prescribing Information… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All DWP devicesDWP Dilator, Vessel, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · DWP
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · DWP
Too few DWP 510(k)s in any year since 2007 to give a median.
Recalls per year · DWP
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DWP
1in 2022
MAUDE reports naming product code DWP, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 3 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 13 |
| 2014 | 0 | — | 0 | 10 |
| 2015 | 0 | — | 0 | 25 |
| 2016 | 0 | — | 0 | 18 |
| 2017 | 1 | — | 0 | 34 |
| 2018 | 0 | — | 0 | 29 |
| 2019 | 1 | — | 0 | 5 |
| 2020 | 0 | — | 0 | 4 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 1 | — | 1 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The disposable Vascular Probe is intended to be used during coronary and peripheral vascular surgery to
probe blood vessels distally and proximally for blockages, to measure the internal diameter of vessels,
and to act as an intravascular retractor.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130896 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130896: Vascular Probe, Vascular Probe ES.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130896
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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