510(k) · Cleared
Recalled · Class II · 2025Performer Introducer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Incorporated · DYB Introducer, Catheter
Cleared on Jul 31, 2017 after a 28-day review. The FDA summary names no predicate by number. 5 later devices descend from it. It has been recalled 2 times.
- Decided
- Jul 31, 2017
- Review
- 28 days
- Class
- Class II
- Product code
- DYB
- Recalls
- 2
- Predicates
- 0
5 later devices descend from it, 4 citing it directly.
- This deviceK171999 Performer IntroducerCook Incorporated · 2017
- Descendant · cites it directly · 1 of its ownK231828 Pounce™ SheathSurmodics,Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK252227 Pounce (TM) SheathSurmodics,Inc. · 2025
- Descendant · cites it directly · 0 of its ownK242520 Element Vascular Access SystemPenumbra, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK230631 Kodiak™ Dual Port Coaxial Introducer KitArgon Medical Devices · 2023
- Descendant · cites it directly · 0 of its ownK173068 Performer IntroducerCook Incorporated · 2017
Most influential descendants
Showing 5 of 5 · See all- K231828Pounce™ SheathSurmodics,Inc. · 2023 · cites it directly1descendant
- K252227Pounce (TM) SheathSurmodics,Inc. · 2025 · 2 generations on0descendants
- K242520Element Vascular Access SystemPenumbra, Inc. · 2024 · cites it directly0descendants
- K230631Kodiak™ Dual Port Coaxial Introducer KitArgon Medical Devices · 2023 · cites it directly0descendants
- K173068Performer IntroducerCook Incorporated · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K171999 | Performer Introducer | Cook Incorporated | 2017 | — |
| +1 | K231828 | Pounce™ Sheath | Surmodics,Inc. | 2023 | — |
| +2 | K252227 | Pounce (TM) Sheath | Surmodics,Inc. | 2025 | — |
| +1 | K242520 | Element Vascular Access System | Penumbra, Inc. | 2024 | — |
| +1 | K230631 | Kodiak™ Dual Port Coaxial Introducer Kit | Argon Medical Devices | 2023 | — |
| +1 | K173068 | Performer Introducer | Cook Incorporated | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 DYB? 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?
The FDA summary names no predicate by number.
What descends from it? (5)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 17, 2025 | Class II | Z-1786-2025 | Under Investigation by firm | Cook Medical identified that devices from the affected device lots may contain the incorrectly sized introducer sheath. |
| Sep 16, 2024 | Class II | Z-0045-2025 | Process control | Cook Medical is conducting removal of a lot of Check-Flo Performer Introducer Set due to complaints that the white caps that connect the shaft to the hub of these products may disconnect. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K231828 (Surmodics,Inc., 2023) has gone furthest, with 1 descendant of its own.
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?
Performer™ Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171999 · printed Nov 5, 2026
Cite this page
510(k) Report. “K171999: Performer Introducer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K171999
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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