510(k) · Cleared
ClearedBrainsuite Net
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Brainlab AG · HAW Neurological Stereotaxic Instrument
Cleared on Sep 25, 2007 as substantially equivalent to K050209 (Smith & Nephew, Inc., 2005) and 1 other predicate after a 210-day review. Its family tree reaches back 8 generations to 1993. 2 later devices descend from it.
- Decided
- Sep 25, 2007
- Review
- 210 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K931783 (1993). 38 ancestors in all, the oldest K801623 (1980). 2 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK931783 Aesop (Automated Endoscopic System for Optimal PosComputer Motion, Inc. · 1993
- 7 generations backK960655 Aesop System and AccessoriesComputer Motion, Inc. · 1996
- 6 generations backK973700 Hermes Operating Room Control CenterComputer Motion, Inc. · 1998
- 5 generations backK980787 Hermes Operating Room Control Center with the Wom 20L InsufflatorComputer Motion, Inc. · 1998
- 4 generations backK990691 Hermes Operating Room Control CenterComputer Motion, Inc. · 1999
- 3 generations backK991444 Hermes Control Center, with Control of the Aesop 3000HR (Hermes…Computer Motion, Inc. · 1999
- 2 generations backK022393 Merdoc SystemStryker Endoscopy · 2003
- 1 generation backK033132 Stryker Switchpoint InfinityStryker Communications Corp. · 2004 · Recalled
- This deviceK070556 Brainsuite NetBrainlab AG · 2007
- Descendant · cites it directly · 1 of its ownK161122 Sony IP Converter NU-IP40SSony Electronics, Inc. · 2016
- Descendant · 2 generations on · 0 of its ownK191678 IP ConverterSony Electronics, Inc. · 2020
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K931783 | Aesop (Automated Endoscopic System for Optimal Pos | Computer Motion, Inc. | 1993 | — |
| −7 | K960655 | Aesop System and Accessories | Computer Motion, Inc. | 1996 | — |
| −6 | K973700 | Hermes Operating Room Control Center | Computer Motion, Inc. | 1998 | — |
| −5 | K980787 | Hermes Operating Room Control Center with the Wom 20L Insufflator | Computer Motion, Inc. | 1998 | — |
| −4 | K990691 | Hermes Operating Room Control Center | Computer Motion, Inc. | 1999 | — |
| −3 | K991444 | Hermes Control Center, with Control of the Aesop 3000HR (Hermes Ready). | Computer Motion, Inc. | 1999 | — |
| −2 | K022393 | Merdoc System | Stryker Endoscopy | 2003 | — |
| −1 | K033132 | Stryker Switchpoint Infinity | Stryker Communications Corp. | 2004 | 11 |
| 0 (this device) | K070556 | Brainsuite Net | Brainlab AG | 2007 | — |
| +1 | K161122 | Sony IP Converter NU-IP40S | Sony Electronics, Inc. | 2016 | — |
| +2 | K191678 | IP Converter | Sony Electronics, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1988 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 8 | 0 |
| 1996 | 5 | 0 |
| 1997 | 4 | 0 |
| 1998 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2020 | 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 HAW? 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 HAW device
- #1 K253856 Geniant Cranial (Navigated Neurosurgical…score 15.0 · 11 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 |
|---|---|---|---|
| * | K050209 | Smith & Nephew Control Digital Operating Room SystemSummary page 1…BrainSUITE NET Common/Classification Name: Instrument, stereotaxic Predicate Devices: Smith & Nephew Control Digital Operating Room System (K050209) Stryker Switch Point Infinity (K033132) Device Classification Name: Instrument, stereotaxic Regulatory Class: Class II Indicati… | 2005 |
| * | K033132 | Stryker Switchpoint InfinitySummary page 1…ification Name: Instrument, stereotaxic Predicate Devices: Smith & Nephew Control Digital Operating Room System (K050209) Stryker Switch Point Infinity (K033132) Device Classification Name: Instrument, stereotaxic Regulatory Class: Class II Indications for Use: BrainSUITE NET from BrainLA… | 2004 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K161122 | Sony IP Converter NU-IP40S | 2016 | 1 |
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 14 years and passes through 4 companies; a new generation was cleared every 1.8 years on median.
- 1 of the 38 ancestors has a recall of any class.
- Of its descendants, K161122 (Sony Electronics, Inc., 2016) has gone furthest, with 1 descendant of its own.
How does its category compare?
All HAW devicesHAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · HAW
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HAW
163in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HAW
2in 2025
Class I (9 since 2007) Class II/III not classified
Adverse event reports per year · HAW
3,425in 2025
MAUDE reports naming product code HAW, 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 | 15 | 107 | 2 | 49 |
| 2008 | 12 | 112 | 10 | 53 |
| 2009 | 8 | 221 | 6 | 96 |
| 2010 | 6 | 138 | 28 | 299 |
| 2011 | 4 | 66 | 5 | 1,725 |
| 2012 | 8 | 178 | 4 | 986 |
| 2013 | 3 | 172 | 6 (1) | 1,290 |
| 2014 | 5 | 238 | 5 | 1,606 |
| 2015 | 10 | 232 | 3 | 1,767 |
| 2016 | 9 | 175 | 5 | 1,828 |
| 2017 | 7 | 226 | 2 | 3,505 |
| 2018 | 6 | 112 | 2 (2) | 4,439 |
| 2019 | 10 | 147 | 4 (1) | 6,062 |
| 2020 | 5 | 88 | 1 | 3,480 |
| 2021 | 9 | 168 | 4 (2) | 2,827 |
| 2022 | 7 | 128 | 1 | 1,929 |
| 2023 | 14 | 142 | 4 (1) | 2,510 |
| 2024 | 7 | 107 | 2 (2) | 3,755 |
| 2025 | 9 | 163 | 2 | 3,425 |
| 2026 | 5 | 162 | 6 | — |
What is it indicated for?
BrainSUITE NET from BrainLAB is a platform for the integration of devices and for the distribution of video signals and multimedia content. It is intended to be used for communication between compatible BrainLAB devices.
It provides centralized access for managing video data, medical images and patient data.
BrainSUITE NET can be used in the operating theater for various surgical procedures involving video processing, image recording, patient data viewing and software application control.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070556 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070556: Brainsuite Net.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070556
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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