510(k) · Cleared
ClearedThe Caterpillar and Caterpillar Micro Arterial Embolization Devices
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
C.R. Bard, Inc. · KRD Device, Vascular, For Promoting Embolization
Cleared on Feb 4, 2020 as substantially equivalent to K071699 (Aga Medical Corp., 2007) after a 239-day review. Its family tree reaches back 8 generations to 1989.
- Decided
- Feb 4, 2020
- Review
- 239 days
- Class
- Class II
- Product code
- KRD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K891688 (1989). 17 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK891688 Coil and Coil Delivery SystemTarget Therapeutics · 1989
- 7 generations backK964367 Ces Vascular Occlusion SystemCordis Neurovascular, Inc. · 1997
- 6 generations backK972881 Ces Vascular Occlusion SystemCordis Neurovascular, Inc. · 1998
- 5 generations backK983483 Vascular Occlusion SystemCordis Neurovascular, Inc. · 1999
- 4 generations backK993455 Flipper Detachable Embolization CoilCook, Inc. · 2000
- 3 generations backK031810 Amplatzer Vascular PlugAga Medical Corp. · 2003 · Recalled
- 2 generations backK071125 Amplatzer Vascular Plug II Models: AVP2-004, AVP2-006, AVP2-008…Aga Medical Corp. · 2007
- 1 generation backK071699 Amplatzer Vascular Plug II, Models AVP2-003, AVP2-018, AVP2-020…Aga Medical Corp. · 2007
- This deviceK191532 The Caterpillar and Caterpillar Micro Arterial Embolization DevicesC.R. Bard, Inc. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K891688 | Coil and Coil Delivery System | Target Therapeutics | 1989 | — |
| −7 | K964367 | Ces Vascular Occlusion System | Cordis Neurovascular, Inc. | 1997 | — |
| −6 | K972881 | Ces Vascular Occlusion System | Cordis Neurovascular, Inc. | 1998 | — |
| −5 | K983483 | Vascular Occlusion System | Cordis Neurovascular, Inc. | 1999 | — |
| −4 | K993455 | Flipper Detachable Embolization Coil | Cook, Inc. | 2000 | — |
| −3 | K031810 | Amplatzer Vascular Plug | Aga Medical Corp. | 2003 | 1 |
| −2 | K071125 | Amplatzer Vascular Plug II Models: AVP2-004, AVP2-006, AVP2-008, AVP2-010… | Aga Medical Corp. | 2007 | — |
| −1 | K071699 | Amplatzer Vascular Plug II, Models AVP2-003, AVP2-018, AVP2-020, AVP2-022 | Aga Medical Corp. | 2007 | — |
| 0 (this device) | K191532 | The Caterpillar and Caterpillar Micro Arterial Embolization Devices | C.R. Bard, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 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 KRD? 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 KRD device
- #1 K253511 Concerto Versa™ Detachable Coilscore 17.6 · 14 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.
What descends from it?
No later submission names this one as a predicate yet.
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 31 years and passes through 5 companies; a new generation was cleared every 3.7 years on median.
- 3 of the 17 ancestors have a recall of any class.
- 1 other device also cites its predicate K071699.
How does its category compare?
All KRD devicesKRD Device, Vascular, For Promoting Embolization: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · KRD
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KRD
60in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KRD
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KRD
1,572in 2025
MAUDE reports naming product code KRD, 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 | 2 | — | 0 | 21 |
| 2008 | 5 | 84 | 0 | 14 |
| 2009 | 4 | 27 | 0 | 40 |
| 2010 | 3 | 150 | 1 | 61 |
| 2011 | 5 | 36 | 0 | 102 |
| 2012 | 8 | 30 | 0 | 137 |
| 2013 | 11 | 33 | 1 | 244 |
| 2014 | 7 | 134 | 0 | 159 |
| 2015 | 11 | 130 | 0 | 337 |
| 2016 | 4 | 164 | 0 | 437 |
| 2017 | 4 | 89 | 0 | 736 |
| 2018 | 4 | 62 | 0 | 1,066 |
| 2019 | 6 | 178 | 0 | 1,185 |
| 2020 | 4 | 137 | 0 | 1,167 |
| 2021 | 3 | 134 | 0 | 1,444 |
| 2022 | 8 | 175 | 0 | 1,498 |
| 2023 | 2 | — | 1 | 1,371 |
| 2024 | 6 | 70 | 1 | 1,535 |
| 2025 | 9 | 60 | 0 | 1,572 |
| 2026 | 7 | 70 | 1 | — |
What is it indicated for?
The Caterpillar and Caterpillar Micro Arterial Embolization Devices are indicated for arterial embolization in the peripheral vasculature. The Caterpillar and Caterpillar Micro Arterial Embolization Devices are contraindicated for use in vessels subject to cyclic bending, such as highly locomotive joints or muscle beds.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191532 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191532: The Caterpillar and Caterpillar Micro Arterial Embolization Devices.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191532
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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