510(k) · Cleared

Recalled · 2005

Stealthstation

K954276510(k) TraditionalCleared Jan 24, 1996133-day reviewClass II21 CFR 882.4560Recalls 1

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

Surgical Navigation Technologies, Inc. · HAW Neurological Stereotaxic Instrument

Cleared on Jan 24, 1996 after a 133-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 7 of the 550 devices in its family, counting itself, have a Class I recall. 549 later devices descend from it. It has been recalled once.

Decided: Jan 24, 1996
Review: 133 days
Class: Class II
Product code: HAW
Recalls: 1
Predicates: 0

549 later devices descend from it, 23 citing it directly. 7 of the 550 devices in this family, counting this one, have a Class I recall.

This deviceK954276 StealthstationSurgical Navigation Technologies, Inc. · 1996
Descendant · cites it directly · 325 of its ownK983529 Instatrak 3000Visualization Technology, Inc. · 1998 · Recalled (Class I)
Descendant · 2 generations on · 294 of its ownK994270 Instatrak 3000 System with Fluorotrak Module, Model IT3000Visualization Technology, Inc. · 2000 · Recalled (Class I)
Descendant · cites it directly · 281 of its ownK981686 Stealthstation System Digitizer ChangeSurgical Navigation Technologies, Inc. · 1998
Descendant · cites it directly · 280 of its ownK040050 Instatrak System with Multiple Dataset Navigation, Model IT3500Ge Medical Systems Navigation and Visualization IN · 2004 · Recalled (Class I)
Descendant · cites it directly · 279 of its ownK992461 Stealthstation Treatment Guidance PlatformSurgical Navigation Technologies, Inc. · 2000

Showing 5 of 549 descendants. See all descendants

Descendants cleared per year

1996high 51 (2020) · low 1 (2001)2026

Class I recalls in this family

K040050 Instatrak System with Multiple Dataset…cites it directly · 2004
K983529 Instatrak 3000cites it directly · 1998
K994270 Instatrak 3000 System with Fluorotrak Module…2 generations on · 2000
K990919 Straight Aspirator, 90 Degree Aspirator,45…2 generations on · 1999

Most influential descendants

Showing 5 of 549 · See all

K983529Instatrak 3000Visualization Technology, Inc. · 1998 · cites it directly325descendants
K994270Instatrak 3000 System with Fluorotrak Module, Model IT3000Visualization Technology, Inc. · 2000 · 2 generations on294descendants
K981686Stealthstation System Digitizer ChangeSurgical Navigation Technologies, Inc. · 1998 · cites it directly281descendants
K040050Instatrak System with Multiple Dataset Navigation, Model IT3500Ge Medical Systems Navigation and Visualization IN · 2004 · cites it directly280descendants
K992461Stealthstation Treatment Guidance PlatformSurgical Navigation Technologies, Inc. · 2000 · cites it directly279descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K954276	Stealthstation	Surgical Navigation Technologies, Inc.	1996	—
+1	K983529	Instatrak 3000	Visualization Technology, Inc.	1998	Class I
+2	K994270	Instatrak 3000 System with Fluorotrak Module, Model IT3000	Visualization Technology, Inc.	2000	Class I
+1	K981686	Stealthstation System Digitizer Change	Surgical Navigation Technologies, Inc.	1998	—
+1	K040050	Instatrak System with Multiple Dataset Navigation, Model IT3500	Ge Medical Systems Navigation and Visualization IN	2004	Class I
+1	K992461	Stealthstation Treatment Guidance Platform	Surgical Navigation Technologies, Inc.	2000	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1996	2	0
1997	5	0
1998	7	1
1999	9	1
2000	2	1
2001	1	0
2002	2	1
2003	2	0
2004	3	1
2005	2	0
2006	4	0
2007	2	0
2008	5	0
2009	6	0
2010	5	0
2011	6	0
2012	12	0
2013	7	0
2014	17	0
2015	26	0
2016	28	0
2017	47	0
2018	30	0
2019	27	0
2020	51	0
2021	36	0
2022	39	0
2023	43	0
2024	34	0
2025	49	2
2026	40	0

FIG. 1 — Lineage of K954276, 1996–2026Source: 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.

7 devices in this family have a Class I recall. 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 has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (549)

See all 549

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

Number	Device	Applicant	Decided	Descendants
K983529	Instatrak 3000 Class I	Visualization Technology, Inc.	1998	325
K981686	Stealthstation System Digitizer Change	Surgical Navigation Technologies, Inc.	1998	281
K040050	Instatrak System with Multiple Dataset Navigation, Model IT3500 Class I	Ge Medical Systems Navigation and Visualization IN	2004	280
K992461	Stealthstation Treatment Guidance Platform	Surgical Navigation Technologies, Inc.	2000	279
K974161	Stealthstation System	Surgical Navigation Technologies, Inc.	1997	279
K053610	Abaris	Traxtal Technologies, Inc.	2006	278
K961168	Viewpoint	Philips Medical Systems (Cleveland), Inc.	1996	161
K984298	Z Kat Flurotactic Guidance System Mki	Z-Kat, Inc.	1999	152
K013025	Modification to Flourolab Plus	Z-Kat, Inc.	2001	151
K063607	Spineassist System	Mazor Surgical Technologies, Ltd.	2007	33

Has anything in its family been recalled? (7 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jan 28, 2005	Not classified	Z-0711-05	Other	The Stealth Station Cranial Application Version 4.5 contains a software anomaly, which may present a hazard to the patient.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K040050Instatrak System with Multiple Dataset Navigation, Model IT3500Ge Medical Systems Navigation and Visualization IN · 2004 · Cites it directly · ◆ in the 2004 descendants bar of FIG. 11 Class I recall
K983529Instatrak 3000Visualization Technology, Inc. · 1998 · Cites it directly · ◆ in the 1998 descendants bar of FIG. 11 Class I recall
K994270Instatrak 3000 System with Fluorotrak Module, Model IT3000Visualization Technology, Inc. · 2000 · 2 generations on · ◆ in the 2000 descendants bar of FIG. 12 Class I recalls
K990919Straight Aspirator, 90 Degree Aspirator,45 Degree Aspirator,7 French Aspirator,Extended Straight…Visualization Technology, Inc. · 1999 · 2 generations on · ◆ in the 1999 descendants bar of FIG. 11 Class I recall
K022069Oec Fluorotrak 9800 PlusGe Oec Medical Systems · 2002 · 3 generations on · ◆ in the 2002 descendants bar of FIG. 11 Class I recall
K242670Lumify Diagnostic Ultrasound SystemPhilips Ultrasound · 2025 · 8 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
K242519Lumify Diagnostic Ultrasound SystemPhilips Ultrasound · 2025 · 8 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall

Nearest 5 of 7; all are on the web page.

What does this lineage say?

Of its descendants, K983529 (Visualization Technology, Inc., 1998) has gone furthest, with 325 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/K954276 · printed Nov 6, 2026

Cite this page

510(k) Report. “K954276: Stealthstation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K954276

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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