510(k) · Cleared
ClearedHummingbird Subdural H900DS (Drainage and Icp), Hummingbird Subdural- H800S (Icp Only)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innerspace, Inc. · GWM Device, Monitoring, Intracranial Pressure
Cleared on May 2, 2012 as substantially equivalent to K013705 (Innerspace, Inc., 2002) after a 196-day review. Its family tree reaches back 1 generation to 2002.
- Decided
- May 2, 2012
- Review
- 196 days
- Class
- Class II
- Product code
- GWM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K013705 (2002). No later device cites it as a predicate yet.
- Root · 1 generation backK013705 Act Iii Ventricular CatheterInnerspace, Inc. · 2002
- This deviceK113088 Hummingbird Subdural H900DS (Drainage and Icp), Hummingbird…Innerspace, Inc. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K013705 | Act Iii Ventricular Catheter | Innerspace, Inc. | 2002 | — |
| 0 (this device) | K113088 | Hummingbird Subdural H900DS (Drainage and Icp), Hummingbird Subdural- H800S… | Innerspace, Inc. | 2012 | — |
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 GWM? 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 GWM device
- #1 K252241 Pressio 3 Multi-parameter Neuromonitoring Systemscore 12.9 · 7 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 |
|---|---|---|---|
| * | K013705 | Act Iii Ventricular CatheterSummary page 1…y: InnerSpace 1622 Edinger Ave. Suite C,Tustin CA 92780 Ph 714 259 7900 Fax 714 259 7999 Contact person: Don Hobo (dboboc~innerspacemedical.com) Predicate 510K Device: K013705 5 10(k) Number Not assigned Device Name Hummingbird Subdural H900DS (Drainage and ICP) Hummingbird Subdural - H800S (ICP… | 2002 |
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K013705.
How does its category compare?
All GWM devicesGWM Device, Monitoring, Intracranial Pressure: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · GWM
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GWM
30in 2020
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GWM
3in 2025
Class I (3 since 2007) Class II/III not classified
Adverse event reports per year · GWM
441in 2025
MAUDE reports naming product code GWM, 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 | 126 |
| 2008 | 2 | — | 1 | 105 |
| 2009 | 1 | — | 0 | 117 |
| 2010 | 2 | — | 9 | 104 |
| 2011 | 3 | 123 | 6 | 184 |
| 2012 | 4 | 100 | 1 | 151 |
| 2013 | 2 | — | 12 | 120 |
| 2014 | 2 | — | 2 | 360 |
| 2015 | 0 | — | 0 | 486 |
| 2016 | 3 | 192 | 0 | 419 |
| 2017 | 3 | 37 | 0 | 445 |
| 2018 | 1 | — | 0 | 302 |
| 2019 | 2 | — | 1 | 260 |
| 2020 | 3 | 30 | 0 | 268 |
| 2021 | 2 | — | 0 | 211 |
| 2022 | 0 | — | 0 | 424 |
| 2023 | 0 | — | 1 (1) | 744 |
| 2024 | 2 | — | 4 (2) | 641 |
| 2025 | 1 | — | 3 | 441 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The use of the Hummingbird H900DS Subdural Catheter is indicated for direct measurement of
intracranial pressure and/or drainage of CSF in the subdural space.
The use of the Hummingbird H800S Subdural Catheter is indicated for direct measurement of
intracranial pressure in the subdural space.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113088 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113088: Hummingbird Subdural H900DS (Drainage and Icp), Hummingbird Subdural- H800S (Icp Only).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113088
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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