510(k) · Cleared

Cleared

Voyager 6.0 Software Option

K000310510(k) SpecialCleared Feb 15, 200014-day reviewClass II21 CFR 882.4560

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Philips Medical Systems (Cleveland), Inc. · HAW Neurological Stereotaxic Instrument

Cleared on Feb 15, 2000 after a 14-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 190 later devices descend from it.

Decided: Feb 15, 2000
Review: 14 days
Class: Class II
Product code: HAW
Recalls: None
Predicates: 0

190 later devices descend from it, 3 citing it directly.

This deviceK000310 Voyager 6.0 Software OptionPhilips Medical Systems (Cleveland), Inc. · 2000
Descendant · cites it directly · 172 of its ownK023975 Voyager LinuxZ-Kat, Inc. · 2002
Descendant · cites it directly · 151 of its ownK013025 Modification to Flourolab PlusZ-Kat, Inc. · 2001
Descendant · 2 generations on · 146 of its ownK031454 Acumen Surgical Navigation SystemBiomet, Inc. · 2004
Descendant · 2 generations on · 97 of its ownK050973 Modification to: Voyager LinuxMako Surgical Corp. · 2005
Descendant · 3 generations on · 96 of its ownK052851 Voyager Linux with Tactile Guidance System (TGS)Mako Surgical Corp. · 2005

Showing 5 of 190 descendants. See all descendants

Descendants cleared per year

2001high 24 (2023) · low 1 (2001)2026

Most influential descendants

Showing 5 of 190 · See all

K023975Voyager LinuxZ-Kat, Inc. · 2002 · cites it directly172descendants
K013025Modification to Flourolab PlusZ-Kat, Inc. · 2001 · cites it directly151descendants
K031454Acumen Surgical Navigation SystemBiomet, Inc. · 2004 · 2 generations on146descendants
K050973Modification to: Voyager LinuxMako Surgical Corp. · 2005 · 2 generations on97descendants
K052851Voyager Linux with Tactile Guidance System (TGS)Mako Surgical Corp. · 2005 · 3 generations on96descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K000310	Voyager 6.0 Software Option	Philips Medical Systems (Cleveland), Inc.	2000	—
+1	K023975	Voyager Linux	Z-Kat, Inc.	2002	—
+1	K013025	Modification to Flourolab Plus	Z-Kat, Inc.	2001	—
+2	K031454	Acumen Surgical Navigation System	Biomet, Inc.	2004	—
+2	K050973	Modification to: Voyager Linux	Mako Surgical Corp.	2005	—
+3	K052851	Voyager Linux with Tactile Guidance System (TGS)	Mako Surgical Corp.	2005	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0
2002	2	0
2003	3	0
2004	1	0
2005	4	0
2006	1	0
2007	1	0
2008	4	0
2009	2	0
2010	2	0
2011	1	0
2012	4	0
2013	5	0
2014	4	0
2015	7	0
2016	7	0
2017	15	0
2018	3	0
2019	12	0
2020	15	0
2021	12	0
2022	14	0
2023	24	0
2024	14	0
2025	19	0
2026	13	0

FIG. 1 — Lineage of K000310, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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

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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (190)

See all 190

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K023975	Voyager Linux	Z-Kat, Inc.	2002	172
K013025	Modification to Flourolab Plus	Z-Kat, Inc.	2001	151
K022239	Surgetics Entact Endonasal Navigation System	Praxim	2002	35

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?

Of its descendants, K023975 (Z-Kat, Inc., 2002) has gone furthest, with 172 descendants of its own.

How does its category compare?

All HAW devices

HAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HAW

9in 2025

2007high 15 (2007) · low 3 (2013)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HAW

163in 2025

2007high 238 (2014) · low 66 (2011)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HAW

2in 2025

2007high 28 (2010) · low 1 (2020)2026

Class I (9 since 2007) Class II/III not classified

Adverse event reports per year · HAW

3,425in 2025

2007high 6,062 (2019) · low 49 (2007)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	—

https://510kreport.com/device/K000310 · printed Nov 6, 2026

Cite this page

510(k) Report. “K000310: Voyager 6.0 Software Option.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K000310

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026