510(k) · Cleared
ClearedEstech Percutaneous Insertion Dilator Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Coombs Medical Device Consulting · DRE Dilator, Vessel, For Percutaneous Catheterization
Cleared on Oct 24, 2007 as substantially equivalent to K963388 (Maxxim Medical, 1997) after a 219-day review. Its family tree reaches back 2 generations to 1989. 10 later devices descend from it.
- Decided
- Oct 24, 2007
- Review
- 219 days
- Class
- Class II
- Product code
- DRE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K891022 (1989). 10 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK891022 Introducer for Ptca Guiding CathetersArgon Medical Corp. · 1989
- 1 generation backK963388 Vessel DilatorMaxxim Medical · 1997
- This deviceK070749 Estech Percutaneous Insertion Dilator KitCoombs Medical Device Consulting · 2007
- Descendant · cites it directly · 4 of its ownK081940 Avalon Elite Vascular Access KitAvalon Laboratories, LLC · 2008 · Recalled
- Descendant · cites it directly · 2 of its ownK093554 Retroflex Dilator KitEdwards Lifesciences, LLC · 2010
- Descendant · 2 generations on · 1 of its ownK162181 Protek Duo Venous Dilator Set, Protek Solo Venous Dilator SetCardiacassist, Inc. · 2017 · Recalled
- Descendant · cites it directly · 1 of its ownK123842 Lawmax DilatorLifetech Scientific (Shenzhen) Co., Ltd. · 2013
- Descendant · cites it directly · 1 of its ownK091542 Estech Easyflow Cannula with GuidewireEndoscopic Technologies, Inc. D/B/A Estech · 2009
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K081940Avalon Elite Vascular Access KitAvalon Laboratories, LLC · 2008 · cites it directly4descendants
- K093554Retroflex Dilator KitEdwards Lifesciences, LLC · 2010 · cites it directly2descendants
- K162181Protek Duo Venous Dilator Set, Protek Solo Venous Dilator SetCardiacassist, Inc. · 2017 · 2 generations on1descendant
- K123842Lawmax DilatorLifetech Scientific (Shenzhen) Co., Ltd. · 2013 · cites it directly1descendant
- K091542Estech Easyflow Cannula with GuidewireEndoscopic Technologies, Inc. D/B/A Estech · 2009 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K891022 | Introducer for Ptca Guiding Catheters | Argon Medical Corp. | 1989 | — |
| −1 | K963388 | Vessel Dilator | Maxxim Medical | 1997 | — |
| 0 (this device) | K070749 | Estech Percutaneous Insertion Dilator Kit | Coombs Medical Device Consulting | 2007 | — |
| +1 | K081940 | Avalon Elite Vascular Access Kit | Avalon Laboratories, LLC | 2008 | 1 |
| +1 | K093554 | Retroflex Dilator Kit | Edwards Lifesciences, LLC | 2010 | — |
| +2 | K162181 | Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set | Cardiacassist, Inc. | 2017 | 1 |
| +1 | K123842 | Lawmax Dilator | Lifetech Scientific (Shenzhen) Co., Ltd. | 2013 | — |
| +1 | K091542 | Estech Easyflow Cannula with Guidewire | Endoscopic Technologies, Inc. D/B/A Estech | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2025 | 2 | 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? (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 |
|---|---|---|---|
| * | K963388 | Vessel DilatorSummary page 1…evice Proprietary Name: ESTECH Percutaneous Dilator Insertion Kit Predicate Device Information: Predicate Devices: Vessel Dilators (K963388) Predicate Device Manufacturers: Maxxim Medical, Inc. a division of Argon… | 1997 |
What descends from it? (10)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 18 years and passes through 3 companies; a new generation was cleared every 10.6 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K081940 (Avalon Laboratories, LLC, 2008) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K963388.
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. 2007, 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 ESTECH Percutaneous Insertion Dilator Kit is intended for use in surgical procedures to aid in percutaneous insertion of a catheter or cannula.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070749 · printed Nov 5, 2026
Cite this page
510(k) Report. “K070749: Estech Percutaneous Insertion Dilator Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K070749
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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