510(k) · Cleared
ClearedCLEAR™ Aspiration System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cleared on Jun 24, 2026 as substantially equivalent to K142870 (Penumbra, Inc., 2015) after a 267-day review. Its family tree reaches back 8 generations to 2001.
- Decided
- Jun 24, 2026
- Review
- 267 days
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K003410 (2001). 10 ancestors in all, the oldest K003086 (2001). No later device cites it as a predicate yet.
- Root · 8 generations backK003410 Concentric Retriever, Model 90030Concentric Medical, Inc. · 2001 · Recalled
- 7 generations backK030476 Modified Concentric Retriever, Model 90037Concentric Medical, Inc. · 2003 · Recalled
- 6 generations backK033736 Merci Retriever, Models 90065, 90066Concentric Medical, Inc. · 2004
- 5 generations backK072718 Penumbra SystemPenumbra, Inc. · 2007 · Recalled
- 4 generations backK100769 Penumbra System Separator Flex (026,032,041,054), Models PSF026…Penumbra, Inc. · 2010
- 3 generations backK113163 Penumbra System MaxPenumbra, Inc. · 2011
- 2 generations backK121917 Penumbra Embolectomy Aspiration SystemPenumbra, Inc. · 2012
- 1 generation backK142870 Penumbra Embolectomy Aspiration System [INDIGO Aspiration System]Penumbra, Inc. · 2015
- This deviceK253404 CLEAR™ Aspiration SystemInsera Therapeutics, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K003410 | Concentric Retriever, Model 90030 | Concentric Medical, Inc. | 2001 | 1 |
| −7 | K030476 | Modified Concentric Retriever, Model 90037 | Concentric Medical, Inc. | 2003 | 2 |
| −6 | K033736 | Merci Retriever, Models 90065, 90066 | Concentric Medical, Inc. | 2004 | — |
| −5 | K072718 | Penumbra System | Penumbra, Inc. | 2007 | 1 |
| −4 | K100769 | Penumbra System Separator Flex (026,032,041,054), Models PSF026, PSF032… | Penumbra, Inc. | 2010 | — |
| −3 | K113163 | Penumbra System Max | Penumbra, Inc. | 2011 | — |
| −2 | K121917 | Penumbra Embolectomy Aspiration System | Penumbra, Inc. | 2012 | — |
| −1 | K142870 | Penumbra Embolectomy Aspiration System [INDIGO Aspiration System] | Penumbra, Inc. | 2015 | — |
| 0 (this device) | K253404 | CLEAR™ Aspiration System | Insera Therapeutics, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2009 | 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 this category? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K142870 | Penumbra Embolectomy Aspiration System [INDIGO Aspiration System]Summary page 5…ference Devices for the CLEARTM Aspiration System 510k Number Name of Device Name of Manufacturer Predicate Device K142870 Predicate for Pump and Entire Aspiration System: Penumbra, Inc. Penumbra Embolectomy Aspiration Sy… | 2015 |
| † | K192981 | Indigo System Aspiration Catheter 12, Indigo Aspiration System Separator 12 | 2020 |
| † | K180939 | Indigo Aspiration System - Modified 110 Aspiration Tubing | 2018 |
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 25 years and passes through 3 companies; a new generation was cleared every 2.4 years on median.
- 3 of the 10 ancestors have a recall of any class.
- 8 other devices also cite its predicate K142870.
What is it indicated for?
The CLEAR Aspiration System is intended for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253404 · printed Nov 4, 2026
Cite this page
510(k) Report. “K253404: CLEAR™ Aspiration System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K253404
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026