510(k) · Cleared
Clearedvan Andel Dilatation Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Incorporated · DRE Dilator, Vessel, For Percutaneous Catheterization
Cleared on Apr 28, 2017 as substantially equivalent to K123842 (Lifetech Scientific (Shenzhen) Co., Ltd., 2013) and 1 other predicate after a 58-day review. Its family tree reaches back 7 generations to 1993.
- Decided
- Apr 28, 2017
- Review
- 58 days
- Class
- Class II
- Product code
- DRE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K924607 (1993). 14 ancestors in all, the oldest K891022 (1989). No later device cites it as a predicate yet.
- Root · 7 generations backK924607 Arrow Fischell Kink Resist Percut Sheath Intro SetArrow Intl., Inc. · 1993 · Recalled
- 6 generations backK012812 Carotid Guiding SheathTerumo Medical Corp. · 2001 · Recalled
- 5 generations backK051601 Pinnacle Destination Peripheral Guiding SheathTerumo Medical Corp. · 2005
- 4 generations backK080415 Device Modification to Pinnacle Destination Peripheral Guiding SheathTerumo Medical Corp. · 2008
- 3 generations backK091329 Pinnacle Destination Peripheral Guiding SheathTerumo Medical Corp. · 2009 · Recalled
- 2 generations backK100799 Fortress Introducer Sheath System Model 358813, 358814, 358815Contract Medical Intl. GmbH · 2011
- 1 generation backK153197 Fortress Introducer Sheath SYstemContract Medical International, GmbH · 2016 · Recalled
- This deviceK170616 van Andel Dilatation CatheterCook Incorporated · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K924607 | Arrow Fischell Kink Resist Percut Sheath Intro Set | Arrow Intl., Inc. | 1993 | 3 |
| −6 | K012812 | Carotid Guiding Sheath | Terumo Medical Corp. | 2001 | 1 |
| −5 | K051601 | Pinnacle Destination Peripheral Guiding Sheath | Terumo Medical Corp. | 2005 | — |
| −4 | K080415 | Device Modification to Pinnacle Destination Peripheral Guiding Sheath | Terumo Medical Corp. | 2008 | — |
| −3 | K091329 | Pinnacle Destination Peripheral Guiding Sheath | Terumo Medical Corp. | 2009 | 1 |
| −2 | K100799 | Fortress Introducer Sheath System Model 358813, 358814, 358815 | Contract Medical Intl. GmbH | 2011 | — |
| −1 | K153197 | Fortress Introducer Sheath SYstem | Contract Medical International, GmbH | 2016 | 1 |
| 0 (this device) | K170616 | van Andel Dilatation Catheter | Cook Incorporated | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1997 | 1 | 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.
Planning a device in DRE? 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 DRE device
- #1 K261310 FlexTract Deflectable-Rotational Dilator…score 12.0 · 2 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 |
|---|---|---|---|
| * | K123842 | Lawmax DilatorSummary page 4…DRE (21 CFR §870.1310) Predicate Device The van Andel Dilatation Catheter is substantially equivalent to the Lawmax Dilator, cleared under K123842, and the Fortress Introducer Sheath System, cleared under K153197. Company Confidential =… | 2013 |
| * | K153197 | Fortress Introducer Sheath SYstemSummary page 4…ice The van Andel Dilatation Catheter is substantially equivalent to the Lawmax Dilator, cleared under K123842, and the Fortress Introducer Sheath System, cleared under K153197. Company Confidential… | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
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 24 years and passes through 5 companies; a new generation was cleared every 2.6 years on median.
- 4 of the 14 ancestors have a recall of any class.
How does its category compare?
All DRE devicesDRE Dilator, Vessel, For Percutaneous Catheterization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · DRE
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DRE
31in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DRE
1in 2016
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · DRE
356in 2025
MAUDE reports naming product code DRE, 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 | 5 | 160 | 0 | 81 |
| 2008 | 2 | — | 0 | 38 |
| 2009 | 2 | — | 2 | 69 |
| 2010 | 1 | — | 2 | 73 |
| 2011 | 1 | — | 1 | 90 |
| 2012 | 1 | — | 0 | 132 |
| 2013 | 4 | 111 | 0 | 120 |
| 2014 | 6 | 72 | 0 | 82 |
| 2015 | 4 | 30 | 1 | 82 |
| 2016 | 3 | 90 | 1 | 84 |
| 2017 | 4 | 108 | 0 | 101 |
| 2018 | 2 | — | 0 | 126 |
| 2019 | 3 | 68 | 0 | 144 |
| 2020 | 3 | 30 | 0 | 120 |
| 2021 | 1 | — | 0 | 115 |
| 2022 | 3 | 261 | 0 | 136 |
| 2023 | 2 | — | 0 | 386 |
| 2024 | 1 | — | 0 | 325 |
| 2025 | 3 | 31 | 0 | 356 |
| 2026 | 1 | — | 1 (1) | — |
What is it indicated for?
The van Andel Dilatation Catheter is intended to facilitate percutaneous introduction of guide wires, catheters, and other devices into the femoral, popliteal, and infrapopliteal arteries during diagnostic and interventional procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170616 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170616: van Andel Dilatation Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170616
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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