510(k) · Cleared
ClearedGunther Tulip Vena Cava Filter Retrieval Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Incorporated · MMX Device, Percutaneous Retrieval
Cleared on May 16, 2023 as substantially equivalent to K181757 (Cook Incorporated, 2018) after a 293-day review. Its family tree reaches back 7 generations to 1990. 1 of the 15 devices in its family, counting itself, has a Class I recall.
- Decided
- May 16, 2023
- Review
- 293 days
- Class
- Class II
- Product code
- MMX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K901502 (1990). 14 ancestors in all. No later device cites it as a predicate yet. 1 of the 15 devices in this family, counting this one, has a Class I recall.
- Root · 7 generations backK901502 Amplatz Goose-Neck SnareMicrovena Corp. · 1990 · Recalled
- 6 generations backK972511 Amplatz Goose Neck Snare Kit/ CatheterMicrovena Corp. · 1998 · Recalled
- 5 generations backK021441 Radius SnareRadius Medical Technologies, Inc. · 2002
- 4 generations backK022201 Radius Micro SnareRadius Medical Technologies, Inc. · 2003
- 3 generations backK032426 Gunhter Tulip Vena Cava Mreye Filter and Retrieval SetCook, Inc. · 2003
- 2 generations backK073374 Cook Clect Vena Cava Filter, Gunther Tulip Vena Cava Filter…William Cook Europe Aps · 2008
- 1 generation backK181757 Günther Tulip® Vena Cava Filter Retrieval SetCook Incorporated · 2018
- This deviceK222254 Gunther Tulip Vena Cava Filter Retrieval SetCook Incorporated · 2023
Class I recalls in this family
- K970466 Radius Ptca Guidewire5 generations back · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K901502 | Amplatz Goose-Neck Snare | Microvena Corp. | 1990 | 1 |
| −6 | K972511 | Amplatz Goose Neck Snare Kit/ Catheter | Microvena Corp. | 1998 | 1 |
| −5 | K021441 | Radius Snare | Radius Medical Technologies, Inc. | 2002 | — |
| −4 | K022201 | Radius Micro Snare | Radius Medical Technologies, Inc. | 2003 | — |
| −3 | K032426 | Gunhter Tulip Vena Cava Mreye Filter and Retrieval Set | Cook, Inc. | 2003 | — |
| −2 | K073374 | Cook Clect Vena Cava Filter, Gunther Tulip Vena Cava Filter Retrieval Set | William Cook Europe Aps | 2008 | — |
| −1 | K181757 | Günther Tulip® Vena Cava Filter Retrieval Set | Cook Incorporated | 2018 | — |
| 0 (this device) | K222254 | Gunther Tulip Vena Cava Filter Retrieval Set | Cook Incorporated | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1993 | 2 | 0 |
| 1997 | 1 | 1 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2007 | 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 MMX device
- #1 K242776 LimFlow V-Ceiverscore 11.0 · 8 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 |
|---|---|---|---|
| * | K181757 | Günther Tulip® Vena Cava Filter Retrieval SetSummary page 4…e: The Günther Tulip Vena Cava Filter Retrieval Set is substantially equivalent to the predicate device: • Günther Tulip Vena Cava Filter Retrieval Set cleared under K181757 on 06 November 2018. Comparison to Predicate Device: It has been demonstrated that the Günther Tulip Vena Cava Filter Re… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
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.
- K970466Radius Ptca GuidewireRadius Medical Technologies, Inc. · 1997 · 5 generations back · ◆ in the 1997 ancestors bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 33 years and passes through 5 companies; a new generation was cleared every 4.4 years on median.
- 3 of the 14 ancestors have a recall of any class; 1 has a Class I recall.
How does its category compare?
All MMX devicesMMX Device, Percutaneous Retrieval: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · MMX
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MMX
151in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MMX
No recall names MMX since 2007.
Adverse event reports per year · MMX
49in 2025
MAUDE reports naming product code MMX, 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 | 1 | — | 0 | 2 |
| 2008 | 0 | — | 0 | 6 |
| 2009 | 2 | — | 0 | 6 |
| 2010 | 1 | — | 0 | 11 |
| 2011 | 1 | — | 0 | 15 |
| 2012 | 1 | — | 0 | 13 |
| 2013 | 0 | — | 0 | 10 |
| 2014 | 2 | — | 0 | 11 |
| 2015 | 2 | — | 0 | 5 |
| 2016 | 2 | — | 0 | 16 |
| 2017 | 2 | — | 0 | 29 |
| 2018 | 1 | — | 0 | 15 |
| 2019 | 1 | — | 0 | 17 |
| 2020 | 2 | — | 0 | 14 |
| 2021 | 1 | — | 0 | 22 |
| 2022 | 3 | 151 | 0 | 37 |
| 2023 | 2 | — | 0 | 40 |
| 2024 | 1 | — | 0 | 32 |
| 2025 | 1 | — | 0 | 49 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The product has been designed for retrieval of implanted Günther Tulip and Cook Celect Vena Cava Filters in patients who no longer require a filter. Retrieval of the filter can be performed only by jugular approach.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222254 · printed Nov 5, 2026
Cite this page
510(k) Report. “K222254: Gunther Tulip Vena Cava Filter Retrieval Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K222254
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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