510(k) · Cleared
Clearedneuro inspire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rensihaw Plc · HAW Neurological Stereotaxic Instrument
Cleared on Sep 15, 2017 as substantially equivalent to K101627 (Brainlab AG, 2011) after a 262-day review. Its family tree reaches back 5 generations to 1999.
- Decided
- Sep 15, 2017
- Review
- 262 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K983410 (1999). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK983410 @ TargetBrainlab AG · 1999
- 4 generations backK020631 IPLANBrainlab AG · 2002
- 3 generations backK041703 IPLAN!Brainlab AG · 2004
- 2 generations backK053127 IPLANBrainlab AG · 2006
- 1 generation backK101627 IPLANBrainlab AG · 2011
- This deviceK163666 neuro inspireRensihaw Plc · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K983410 | @ Target | Brainlab AG | 1999 | — |
| −4 | K020631 | IPLAN | Brainlab AG | 2002 | — |
| −3 | K041703 | IPLAN! | Brainlab AG | 2004 | — |
| −2 | K053127 | IPLAN | Brainlab AG | 2006 | — |
| −1 | K101627 | IPLAN | Brainlab AG | 2011 | — |
| 0 (this device) | K163666 | neuro inspire | Rensihaw Plc | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 3 | 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? (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 |
|---|---|---|---|
| * | K101627 | IPLANSummary page 4…Stereotaxic instrument Product code: HAW 3. Predicate device: Brainlab AG iPlan Stereotaxy K101627 Device Classification Name: Stereotaxic Instrument Regulatory Class: Class II… | 2011 |
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 18 years and passes through 2 companies; a new generation was cleared every 3.0 years on median.
- None of the 8 ancestors has a recall.
- 2 other devices also cite its predicate K101627.
How does its category compare?
All HAW devicesHAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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?
neuroinspire is a stereotactic software application intended to allow trained clinicians to plan surgical trajectories for neurological procedures. neuroinspire defines a stereotactic region for this planning based on fiducial markers in CT images. neuroinspire reports specific surgical trajectories intended to be manually set on head frame systems validated for use with neuroinspire. neuroinspire has been validated with the Leksell Stereotactic System…
Read the full statement (114 words)
neuroinspire is a stereotactic software application intended to allow trained clinicians to plan surgical trajectories for neurological procedures. neuroinspire defines a stereotactic region for this planning based on fiducial markers in CT images. neuroinspire reports specific surgical trajectories intended to be manually set on head frame systems validated for use with neuroinspire. neuroinspire has been validated with the Leksell Stereotactic System Type G (comprising of head ring, head frame and CT Localizer). No other components of the Leksell Stereotactic System should be used. No other stereotactic system should be used. The user should consult Section 1.7 Accuracy of these Instructions for Use to assess if the accuracy of neuroinspire is suitable for their needs.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163666 · printed Nov 6, 2026
Cite this page
510(k) Report. “K163666: neuro inspire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K163666
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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