510(k) · Cleared
ClearedPeel-Away Introducer Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Incorporated · DYB Introducer, Catheter
Cleared on Sep 28, 2017 as substantially equivalent to K153533 (Galt Medical Corp., 2016) and 1 other predicate after a 268-day review. Its family tree reaches back 5 generations to 2000. 1 of the 15 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Sep 28, 2017
- Review
- 268 days
- Class
- Class II
- Product code
- DYB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K000313 (2000). 13 ancestors in all, the oldest K852363 (1985). 1 later device descends from it, 1 citing it directly. 1 of the 15 devices in this family, counting this one, has a Class I recall.
- Root · 5 generations backK000313 Tearaway Introducer SheathXentek Medical, Inc. · 2000 · Recalled
- 4 generations backK043525 Catheter IntroducerGalt Medical Corp. · 2005 · Recalled
- 3 generations backK112398 Triv (TM) Valved Tearaway Introducer, Tirv (TM) Valved Tearaway…Galt Medical · 2012 · Recalled
- 2 generations backK123430 Microslider Tearaway Introducer SetGalt Medical Corp. · 2013
- 1 generation backK153533 Tearaway Introducer Sheath, MicroSlide Tearaway IntroducerGalt Medical Corp. · 2016 · Recalled
- This deviceK170020 Peel-Away Introducer SetCook Incorporated · 2017
- Descendant · cites it directly · 0 of its ownK173685 Peel-Away Introducer SetCook Incorporated · 2017
Class I recalls in this family
- K921370 Mic Gastro-Enterostomy Tube Modification3 generations back · 1994
Most influential descendants
Showing 1 of 1 · See all- K173685Peel-Away Introducer SetCook Incorporated · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K000313 | Tearaway Introducer Sheath | Xentek Medical, Inc. | 2000 | 1 |
| −4 | K043525 | Catheter Introducer | Galt Medical Corp. | 2005 | 3 |
| −3 | K112398 | Triv (TM) Valved Tearaway Introducer, Tirv (TM) Valved Tearaway Introducer… | Galt Medical | 2012 | 2 |
| −2 | K123430 | Microslider Tearaway Introducer Set | Galt Medical Corp. | 2013 | — |
| −1 | K153533 | Tearaway Introducer Sheath, MicroSlide Tearaway Introducer | Galt Medical Corp. | 2016 | 2 |
| 0 (this device) | K170020 | Peel-Away Introducer Set | Cook Incorporated | 2017 | — |
| +1 | K173685 | Peel-Away Introducer Set | Cook Incorporated | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1994 | 2 | 1 |
| 1995 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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.
1 device in this family has 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 DYB device
- #1 K251051 AuST Steerable Sheathscore 18.0 · 10 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 |
|---|---|---|---|
| * | K153533 | Tearaway Introducer Sheath, MicroSlide Tearaway IntroducerSummary page 4…21 CFR §876.5980, 21 CFR §870.1340 Product Code: DYB, KGC Predicate Devices: Primary: Galt Medical Tearaway Introducer Sheath (K153533) Secondary: Kimberly-Clark Enteral Access Dilation System (K093312) Device Description: Cook’s Peel-Away® Introd… | 2016 |
| * | K093312 | Kimberly-Clark Gastrointestinal Anchor Set with Saf-T-Pexy Fasteners, Enternal Access…Summary page 4…Predicate Devices: Primary: Galt Medical Tearaway Introducer Sheath (K153533) Secondary: Kimberly-Clark Enteral Access Dilation System (K093312) Device Description: Cook’s Peel-Away® Introducer Sets are single-use, sterile, disposable products that are used to provide ini… | 2009 |
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 |
|---|---|---|---|
| K173685 | Peel-Away Introducer Set | 2017 | 0 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
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.
- K921370Mic Gastro-Enterostomy Tube ModificationMedical Innovations Corp. · 1994 · 3 generations back · ◆ in the 1994 ancestors bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 17 years and passes through 4 companies; a new generation was cleared every 3.2 years on median.
- 6 of the 13 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K173685 (Cook Incorporated, 2017) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K153533.
How does its category compare?
All DYB devicesDYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · DYB
16in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DYB
63in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DYB
3in 2025
Class I (48 since 2007) Class II/III not classified
Adverse event reports per year · DYB
4,539in 2025
MAUDE reports naming product code DYB, 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 | 12 | 95 | 15 | 316 |
| 2008 | 17 | 37 | 9 | 423 |
| 2009 | 14 | 52 | 25 | 399 |
| 2010 | 18 | 123 | 18 | 445 |
| 2011 | 17 | 100 | 4 | 628 |
| 2012 | 22 | 128 | 3 | 898 |
| 2013 | 26 | 118 | 5 (1) | 743 |
| 2014 | 30 | 122 | 2 | 780 |
| 2015 | 17 | 129 | 2 (1) | 913 |
| 2016 | 19 | 95 | 45 (3) | 1,234 |
| 2017 | 24 | 70 | 22 (1) | 1,672 |
| 2018 | 19 | 156 | 1 | 1,903 |
| 2019 | 18 | 47 | 2 | 2,450 |
| 2020 | 9 | 49 | 21 (21) | 2,465 |
| 2021 | 12 | 78 | 6 | 2,835 |
| 2022 | 13 | 143 | 2 | 4,084 |
| 2023 | 15 | 55 | 10 | 3,775 |
| 2024 | 18 | 56 | 2 | 3,931 |
| 2025 | 16 | 63 | 3 | 4,539 |
| 2026 | 17 | 59 | 23 (21) | — |
What is it indicated for?
The Peel-Away Introducer Set is intended for the percutaneous introduction of balloon, electrode and closed or non-tapered end catheters into central and peripheral vasculature, and for non-vascular use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170020 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170020: Peel-Away Introducer Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170020
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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