510(k) · Cleared
ClearedPenumbra Pump Max (110VAC), Penumbra Pump Max (230VAC), Penumbar Pump Max Canister/Tubing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Penumbra, Inc. · JCX Apparatus, Suction, Ward Use, Portable, Ac-Powered
Cleared on Oct 2, 2012 after a 25-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 5 of the 46 devices in its family, counting itself, have a Class I recall. 45 later devices descend from it.
- Decided
- Oct 2, 2012
- Review
- 25 days
- Class
- Class II
- Product code
- JCX
- Recalls
- None
- Predicates
- 1
45 later devices descend from it, 8 citing it directly. 5 of the 46 devices in this family, counting this one, have a Class I recall.
- This deviceK122756 Penumbra Pump Max (110VAC), Penumbra Pump Max (230VAC), Penumbar…Penumbra, Inc. · 2012
- Descendant · cites it directly · 31 of its ownK160449 Penumbra System, Penumbra Pump MAXPenumbra, Inc. · 2016
- Descendant · 2 generations on · 17 of its ownK161640 Penumbra System ACE 68 Reperfusion CatheterPenumbra, Inc. · 2016
- Descendant · 2 generations on · 16 of its ownK162901 Penumbra 3D Revascularization DevicePenumbra, Inc. · 2017 · Recalled (Class I)
- Descendant · 3 generations on · 10 of its ownK173761 Penumbra System Reperfusion Catheter JET 7Penumbra, Inc. · 2018
- Descendant · 2 generations on · 6 of its ownK173841 AXS Catalyst Distal Access Catheter 058 x 115cm; AXS Catalyst Distal…Stryker · 2018
Showing 5 of 45 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 45 · See all- K160449Penumbra System, Penumbra Pump MAXPenumbra, Inc. · 2016 · cites it directly31descendants
- K161640Penumbra System ACE 68 Reperfusion CatheterPenumbra, Inc. · 2016 · 2 generations on17descendants
- K162901Penumbra 3D Revascularization DevicePenumbra, Inc. · 2017 · 2 generations on16descendants
- K173761Penumbra System Reperfusion Catheter JET 7Penumbra, Inc. · 2018 · 3 generations on10descendants
- K173841AXS Catalyst Distal Access Catheter 058 x 115cm; AXS Catalyst Distal Access Catheter 058…Stryker · 2018 · 2 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K122756 | Penumbra Pump Max (110VAC), Penumbra Pump Max (230VAC), Penumbar Pump Max… | Penumbra, Inc. | 2012 | — |
| +1 | K160449 | Penumbra System, Penumbra Pump MAX | Penumbra, Inc. | 2016 | — |
| +2 | K161640 | Penumbra System ACE 68 Reperfusion Catheter | Penumbra, Inc. | 2016 | — |
| +2 | K162901 | Penumbra 3D Revascularization Device | Penumbra, Inc. | 2017 | Class I |
| +3 | K173761 | Penumbra System Reperfusion Catheter JET 7 | Penumbra, Inc. | 2018 | — |
| +2 | K173841 | AXS Catalyst Distal Access Catheter 058 x 115cm; AXS Catalyst Distal Access… | Stryker | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 3 | 1 |
| 2018 | 8 | 0 |
| 2019 | 4 | 1 |
| 2020 | 4 | 2 |
| 2021 | 3 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 1 |
| 2024 | 4 | 0 |
| 2025 | 6 | 0 |
| 2026 | 5 | 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.
5 devices in this family have 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 JCX device
- #1 K250964 Protable Phlegm Suction Unit (JMA D01)score 12.2 · 4 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K081758 | FDA’s K081758 is Healos FX Injectable Bone Graft Replacement, Models 276175002, 276175005… Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2008 |
What descends from it? (45)
See all 458 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K160449 | Penumbra System, Penumbra Pump MAX | 2016 | 31 |
| K132931 | Apollo System | 2014 | 5 |
| K180115 | TWBM Pump | 2018 | 1 |
| K243638 | MV Flow Aspiration Pump (MVFLOWPMP01) | 2025 | 0 |
| K243418 | Riptide™ Aspiration Pump; Riptide™ Collection Canister with Intermediate Tubing | 2024 | 0 |
| K232831 | Quiver Aspiration Pump | 2024 | 0 |
| K233428 | Easycess Aspiration Pump | 2023 | 0 |
| K181398 | DV-300 Aspirator | 2018 | 0 |
Has anything in its family been recalled? (5 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.
- K162901Penumbra 3D Revascularization DevicePenumbra, Inc. · 2017 · 2 generations on · ◆ in the 2017 descendants bar of FIG. 11 Class I recall
- K190010Penumbra System Reperfusion Catheter JET 7Penumbra, Inc. · 2019 · 4 generations on · ◆ in the 2019 descendants bar of FIG. 14 Class I recalls
- K191946Penumbra System Penumbra JET 7XPenumbra, Inc. · 2020 · 5 generations on · ◆ in the 2020 descendants bar of FIG. 14 Class I recalls
- K202251Penumbra System (Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology; Penumbra JET 7MAX)Penumbra, Inc. · 2020 · 5 generations on · ◆ in the 2020 descendants bar of FIG. 14 Class I recalls
- K222786072 Aspiration SystemQ'Apel Medical, Inc. · 2023 · 6 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K160449 (Penumbra, Inc., 2016) has gone furthest, with 31 descendants of its own.
How does its category compare?
All JCX devicesJCX Apparatus, Suction, Ward Use, Portable, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · JCX
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JCX
30in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JCX
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JCX
45in 2025
MAUDE reports naming product code JCX, 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 | 0 | — | 0 | 48 |
| 2008 | 4 | 43 | 3 | 57 |
| 2009 | 1 | — | 0 | 34 |
| 2010 | 1 | — | 0 | 7 |
| 2011 | 2 | — | 2 | 9 |
| 2012 | 2 | — | 0 | 18 |
| 2013 | 5 | 144 | 2 | 12 |
| 2014 | 4 | 106 | 0 | 68 |
| 2015 | 0 | — | 0 | 118 |
| 2016 | 2 | — | 0 | 119 |
| 2017 | 2 | — | 1 | 102 |
| 2018 | 2 | — | 0 | 170 |
| 2019 | 3 | 30 | 0 | 132 |
| 2020 | 0 | — | 1 | 89 |
| 2021 | 0 | — | 0 | 227 |
| 2022 | 1 | — | 0 | 215 |
| 2023 | 1 | — | 0 | 187 |
| 2024 | 1 | — | 0 | 103 |
| 2025 | 2 | — | 0 | 45 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
The Penumbra Pump MIAXTM is intended for general suction use in hospitals or clinics.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122756 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122756: Penumbra Pump Max (110VAC), Penumbra Pump Max (230VAC), Penumbar Pump Max Canister/Tubing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122756
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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