510(k) · Cleared
ClearedZ-BOX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Z-Kat, Inc. · HAW Neurological Stereotaxic Instrument
Cleared on Apr 24, 2003 as substantially equivalent to K023975 (Z-Kat, Inc., 2002) after a 44-day review. Its family tree reaches back 2 generations to 2000. 2 later devices descend from it.
- Decided
- Apr 24, 2003
- Review
- 44 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K000310 (2000). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK000310 Voyager 6.0 Software OptionPhilips Medical Systems (Cleveland), Inc. · 2000
- 1 generation backK023975 Voyager LinuxZ-Kat, Inc. · 2002
- This deviceK030764 Z-BOXZ-Kat, Inc. · 2003
- Descendant · cites it directly · 0 of its ownK051724 Acumen Image Guided Surgical SystemEbi, L.P. · 2005
- Descendant · cites it directly · 0 of its ownK031732 Ebi Acumen Surgical Navigation SystemEbi, L.P. · 2003
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 |
|---|---|---|---|---|---|
| −2 | K000310 | Voyager 6.0 Software Option | Philips Medical Systems (Cleveland), Inc. | 2000 | — |
| −1 | K023975 | Voyager Linux | Z-Kat, Inc. | 2002 | — |
| 0 (this device) | K030764 | Z-BOX | Z-Kat, Inc. | 2003 | — |
| +1 | K051724 | Acumen Image Guided Surgical System | Ebi, L.P. | 2005 | — |
| +1 | K031732 | Ebi Acumen Surgical Navigation System | Ebi, L.P. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 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? (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 |
|---|---|---|---|
| * | K023975 | Voyager Linux | 2002 |
What descends from it? (2)
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?
- The line of descent spans 3 years and passes through 2 companies; a new generation was cleared every 2.8 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K051724 (Ebi, L.P., 2005) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K023975.
How does its category compare?
All HAW devicesHAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
2-Box is intended for use as a device which uses diagnostic images of the patient acquired specifically to assist the physician with presurgical planning and to provide orientation and reference information during intra-operative procedures. 2-Box is indicated for any medical condition in which the use of stereotactic surgery may be considered to be safe and effective, and where a reference to a rigid anatomical structure may be made, such as…
Read the full statement (103 words)
2-Box is intended for use as a device which uses diagnostic images of the patient acquired specifically to assist the physician with presurgical planning and to provide orientation and reference information during intra-operative procedures.
2-Box is indicated for any medical condition in which the use of stereotactic surgery may be considered to be safe and effective, and where a reference to a rigid anatomical structure may be made, such as:
Intra-cranial surgical procedures involving space occupying lesions or malformations (including soft tissue, vascular and osseous)
Spinal surgical procedures involving spinal stabilization, neural decompression, or resection of spinal neoplasms
ENT Procedures
Orthopedic surgical procedure
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030764 · printed Nov 4, 2026
Cite this page
510(k) Report. “K030764: Z-BOX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K030764
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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