510(k) · Cleared
ClearedApollo System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Penumbra, Inc. · GWG Endoscope, Neurological
Cleared on Jan 17, 2014 as substantially equivalent to K983365 (Aesculap, Inc., 1998) and 1 other predicate after a 121-day review. Its family tree reaches back 1 generation to 1998. 5 later devices descend from it.
- Decided
- Jan 17, 2014
- Review
- 121 days
- Class
- Class II
- Product code
- GWG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K983365 (1998). 2 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK983365 Aesculap Minop SystemAesculap, Inc. · 1998 · Recalled
- This deviceK132931 Apollo SystemPenumbra, Inc. · 2014
- Descendant · cites it directly · 4 of its ownK152699 Apollo SystemPenumbra, Inc. · 2016
- Descendant · cites it directly · 2 of its ownK171332 Artemis Neuro Evacuation DevicePenumbra, Inc. · 2017
- Descendant · 2 generations on · 1 of its ownK201308 Axonpen, Axonmonitor, Axonbox, TabletClearmind Biomedical · 2020
- Descendant · 3 generations on · 0 of its ownK230125 Neuroblade SystemClearmind Biomedical · 2023
- Descendant · 2 generations on · 0 of its ownK181731 MR Compatible Aspiration KitMri Interventions, Inc. · 2018
Most influential descendants
Showing 5 of 5 · See all- K152699Apollo SystemPenumbra, Inc. · 2016 · cites it directly4descendants
- K171332Artemis Neuro Evacuation DevicePenumbra, Inc. · 2017 · cites it directly2descendants
- K201308Axonpen, Axonmonitor, Axonbox, TabletClearmind Biomedical · 2020 · 2 generations on1descendant
- K230125Neuroblade SystemClearmind Biomedical · 2023 · 3 generations on0descendants
- K181731MR Compatible Aspiration KitMri Interventions, Inc. · 2018 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K983365 | Aesculap Minop System | Aesculap, Inc. | 1998 | 3 |
| 0 (this device) | K132931 | Apollo System | Penumbra, Inc. | 2014 | — |
| +1 | K152699 | Apollo System | Penumbra, Inc. | 2016 | — |
| +1 | K171332 | Artemis Neuro Evacuation Device | Penumbra, Inc. | 2017 | — |
| +2 | K201308 | Axonpen, Axonmonitor, Axonbox, Tablet | Clearmind Biomedical | 2020 | — |
| +3 | K230125 | Neuroblade System | Clearmind Biomedical | 2023 | — |
| +2 | K181731 | MR Compatible Aspiration Kit | Mri Interventions, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 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 GWG? 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 GWG device
- #1 K211202 1688 4K Camera System, L11 LED Light Source…score 22.5 · 20 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K983365 | Aesculap Minop SystemSummary page 1…____________________________State) _ ________ AsuaAsiainCnuaAesculap, Inc. K983365 Aesclap spiatio CanulaCenter Valley, PA PnmrPupMXm Penumb… | 1998 |
| * | K122756 | Penumbra Pump Max (110VAC), Penumbra Pump Max (230VAC), Penumbar Pump Max Canister/TubingSummary page 1…K983365 Aesclap spiatio CanulaCenter Valley, PA PnmrPupMXm Penumbra, Inc. K122756 Penubra ump AXTM Alameda, CA… | 2012 |
What descends from it? (5)
2 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All GWG devicesGWG Endoscope, Neurological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · GWG
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GWG
269in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GWG
2in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GWG
33in 2025
MAUDE reports naming product code GWG, 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 | 3 |
| 2008 | 2 | — | 0 | 5 |
| 2009 | 0 | — | 1 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 2 | 4 |
| 2012 | 0 | — | 0 | 7 |
| 2013 | 1 | — | 0 | 3 |
| 2014 | 2 | — | 0 | 19 |
| 2015 | 0 | — | 0 | 37 |
| 2016 | 2 | — | 0 | 25 |
| 2017 | 4 | 126 | 0 | 12 |
| 2018 | 4 | 128 | 0 | 16 |
| 2019 | 3 | 156 | 0 | 10 |
| 2020 | 2 | — | 0 | 19 |
| 2021 | 3 | 106 | 0 | 21 |
| 2022 | 0 | — | 0 | 12 |
| 2023 | 5 | 269 | 0 | 9 |
| 2024 | 1 | — | 0 | 9 |
| 2025 | 2 | — | 0 | 33 |
| 2026 | 4 | 217 | 0 | — |
What is it indicated for?
The ApolloTM System is used for the controlled aspiration of tissue and/or fluids during surgery of the Ventricular System. The ApolloTM disposable wand is inserted through the working channel of a neuroendoscopic trocar.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132931 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132931: Apollo System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132931
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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