510(k) · Cleared
ClearedCranial Reducing Tubes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Navigation, Inc. · HAW Neurological Stereotaxic Instrument
Cleared on Dec 30, 2016 as substantially equivalent to K992304 (Image-Guided Neurologics, Inc., 1999) and 1 other predicate after a 102-day review. Its family tree reaches back 1 generation to 1999. 1 later device descends from it.
- Decided
- Dec 30, 2016
- Review
- 102 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K992304 (1999). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K253663Zeta Navigation SystemZeta Surgical, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K992304 | Navigus Trajectory Guide, Model TG-XXXX | Image-Guided Neurologics, Inc. | 1999 | — |
| 0 (this device) | K162604 | Cranial Reducing Tubes | Medtronic Navigation, Inc. | 2016 | — |
| +1 | K253663 | Zeta Navigation System | Zeta Surgical, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 |
|---|---|---|---|
| * | K992304 | Navigus Trajectory Guide, Model TG-XXXXSummary page 4…ication Name: Stereotaxic Instrument (21 CFR 882.4560) Regulatory Class: Class II (21 CFR 882.4560) Product Code: HAW III. PREDICATE DEVICE Navigus Trajectory Guide, K992304 (Medtronic Neuromodulation) Navigus II Trajectory Guide, K012366 (Medtronic Neuromodulation) No reference devices were used in t… | 1999 |
| * | K012366 | Navigus II Trajectory GuideSummary page 4…Class: Class II (21 CFR 882.4560) Product Code: HAW III. PREDICATE DEVICE Navigus Trajectory Guide, K992304 (Medtronic Neuromodulation) Navigus II Trajectory Guide, K012366 (Medtronic Neuromodulation) No reference devices were used in this submission. IV. DEVICE DESCRIPTION The Medtronic Cranial… | 2001 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K253663 | Zeta Navigation System | 2026 | 0 |
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 HAW devicesHAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
The Cranial Reducing Tubes are intended to maintain the position of instruments or devices placed using stereotactic guidance during planning and operation of neurological procedures performed in conjunction with the use of the Medtronic StealthStation System Image Guided Workstation. The devices were not tested for MR compatibility, and are not intended for use in an MRI environment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162604 · printed Nov 5, 2026
Cite this page
510(k) Report. “K162604: Cranial Reducing Tubes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K162604
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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