510(k) · Cleared
Recalled · Class II · 2024Dilator Sets
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 Dec 20, 2018 as substantially equivalent to K162389 (Medcomp ( Medical Components), 2017) and 1 other predicate after a 49-day review. Its family tree reaches back 2 generations to 1996. 1 later device descends from it. It has been recalled 3 times.
- Decided
- Dec 20, 2018
- Review
- 49 days
- Class
- Class II
- Product code
- DRE
- Recalls
- 3
- Predicates
- 2
Its longest line of descent runs back 2 generations to K961904 (1996). 4 ancestors in all, the oldest K801113 (1980). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK961904 AQ Hydrophilic DilatorsCook Urological, Inc. · 1996
- 1 generation backK990808 PBN DilatorsMedical Device Technologies, Inc. · 1999
- This deviceK183036 Dilator SetsCook Incorporated · 2018
- Descendant · cites it directly · 0 of its ownK210734 Endovascular Dilator and SetsCook Incorporated · 2021
Most influential descendants
Showing 1 of 1 · See all- K210734Endovascular Dilator and SetsCook Incorporated · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K961904 | AQ Hydrophilic Dilators | Cook Urological, Inc. | 1996 | — |
| −1 | K990808 | PBN Dilators | Medical Device Technologies, Inc. | 1999 | — |
| 0 (this device) | K183036 | Dilator Sets | Cook Incorporated | 2018 | — |
| +1 | K210734 | Endovascular Dilator and Sets | Cook Incorporated | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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 |
|---|---|---|---|
| * | K162389 | Medcomp Vessel DilatorSummary page 4…logy Regulation: 21 CFR §870.1310, 21 CFR §876.5010 Product Code: DRE, FGE Predicate Devices: ▪ Medcomp® Vessel Dilator (Medcomp®, K162389) ▪ PBN Dilators (Medical Device Technologies, Inc., K990808) Reference Devices: ▪ Peel-Away Introducer Set (Cook Inc., K170020)… | 2017 |
| * | K990808 | PBN DilatorsSummary page 4…876.5010 Product Code: DRE, FGE Predicate Devices: ▪ Medcomp® Vessel Dilator (Medcomp®, K162389) ▪ PBN Dilators (Medical Device Technologies, Inc., K990808) Reference Devices: ▪ Peel-Away Introducer Set (Cook Inc., K170020) ▪ Royal Flush Catheter (Cook Inc., K171264) ▪ CrossCath Suppo… | 1999 |
| † | K170020 | Peel-Away Introducer Set | 2017 |
| † | K171264 | Royal Flush Catheter | 2018 |
| † | K161801 | CrossCath Support Catheter | 2016 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K210734 | Endovascular Dilator and Sets | 2021 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 1, 2024 | Class II | Z-1532-2024 | Under Investigation by firm | Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility |
| Mar 1, 2024 | Class II | Z-1530-2024 | Under Investigation by firm | Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility |
| Mar 1, 2024 | Class II | Z-1531-2024 | Under Investigation by firm | Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 3 companies; a new generation was cleared every 19.1 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K210734 (Cook Incorporated, 2021) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K162389.
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. 2018, 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?
Intended to be used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular applications such as in the venous, arterial, biliary and renal systems.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K183036 · printed Nov 4, 2026
Cite this page
510(k) Report. “K183036: Dilator Sets.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K183036
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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