510(k) · Cleared

Cleared

Vectorvision

K962939510(k) TraditionalCleared May 22, 1997297-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

Brainlab, Inc. · HAW Neurological Stereotaxic Instrument

Cleared on May 22, 1997 after a 297-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 153 later devices descend from it.

Decided: May 22, 1997
Review: 297 days
Class: Class II
Product code: HAW
Recalls: None
Predicates: 0

153 later devices descend from it, 2 citing it directly.

This deviceK962939 VectorvisionBrainlab, Inc. · 1997
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 · 81 of its ownK031337 Acumen Surgical Navigation SystemBiomet, Inc. · 2003
Descendant · 3 generations on · 78 of its ownK072806 Mako Surgical Tactile Guidance System (TGS)Mako Surgical Corp. · 2008 · Recalled
Descendant · 3 generations on · 76 of its ownK081867 Mako Surgical Tactile Guidance System Version 2.0Mako Surgical Corp. · 2008 · Recalled

Showing 5 of 153 descendants. See all descendants

Descendants cleared per year

1998high 20 (2023) · low 0 (1999)2026

Most influential descendants

Showing 5 of 153 · See all

K013025Modification to Flourolab PlusZ-Kat, Inc. · 2001 · cites it directly151descendants
K031454Acumen Surgical Navigation SystemBiomet, Inc. · 2004 · 2 generations on146descendants
K031337Acumen Surgical Navigation SystemBiomet, Inc. · 2003 · 2 generations on81descendants
K072806Mako Surgical Tactile Guidance System (TGS)Mako Surgical Corp. · 2008 · 3 generations on78descendants
K081867Mako Surgical Tactile Guidance System Version 2.0Mako Surgical Corp. · 2008 · 3 generations on76descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K962939	Vectorvision	Brainlab, Inc.	1997	—
+1	K013025	Modification to Flourolab Plus	Z-Kat, Inc.	2001	—
+2	K031454	Acumen Surgical Navigation System	Biomet, Inc.	2004	—
+2	K031337	Acumen Surgical Navigation System	Biomet, Inc.	2003	—
+3	K072806	Mako Surgical Tactile Guidance System (TGS)	Mako Surgical Corp.	2008	1
+3	K081867	Mako Surgical Tactile Guidance System Version 2.0	Mako Surgical Corp.	2008	2

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
2001	1	0
2003	2	0
2004	1	0
2005	1	0
2006	1	0
2008	2	0
2009	2	0
2010	1	0
2012	4	0
2013	3	0
2014	2	0
2015	6	0
2016	5	0
2017	11	0
2018	2	0
2019	10	0
2020	12	0
2021	9	0
2022	14	0
2023	20	0
2024	14	0
2025	18	0
2026	11	0

FIG. 1 — Lineage of K962939, 1997–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (153)

See all 153

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

Number	Device	Applicant	Decided	Descendants
K013025	Modification to Flourolab Plus	Z-Kat, Inc.	2001	151
K980820	Philips Easyguide	Philips Medical Systems, Inc.	1998	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?

Of its descendants, K013025 (Z-Kat, Inc., 2001) has gone furthest, with 151 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	—

What is it indicated for?

Frameless stereotactic cranial neurosurgery and intraoperative surgical guidance.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K962939 · printed Nov 5, 2026

Cite this page

510(k) Report. “K962939: Vectorvision.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K962939

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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