510(k) · Cleared

Recalled · Class I · 2013

Instatrak

K960330510(k) TraditionalCleared Apr 8, 199675-day reviewClass II21 CFR 892.2050Recalls 9 (1 Class I)

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

Visualization Technology, Inc. · LLZ System, Image Processing, Radiological

Cleared on Apr 8, 1996 after a 75-day review. The FDA summary names its predicate without a number. 9 of the 329 devices in its family, counting itself, have a Class I recall. 328 later devices descend from it. It has been recalled 9 times, including a Class I recall.

Decided: Apr 8, 1996
Review: 75 days
Class: Class II
Product code: LLZ
Recalls: 9 (1 Class I)
Predicates: 0

328 later devices descend from it, 8 citing it directly. 9 of the 329 devices in this family, counting this one, have a Class I recall.

This deviceK960330 InstatrakVisualization Technology, Inc. · 1996
Descendant · cites it directly · 327 of its ownK981998 Pediatric Instatrak SystemVisualization Technology, Inc. · 1998 · Recalled (Class I)
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 · 280 of its ownK982994 Skull Base Instatrak SystemVisualization Technology, Inc. · 1998 · Recalled (Class I)
Descendant · cites it directly · 278 of its ownK053610 AbarisTraxtal Technologies, Inc. · 2006 · Recalled

Showing 5 of 328 descendants. See all descendants

Descendants cleared per year

1998high 35 (2020) · low 0 (2001)2026

Class I recalls in this family

K981998 Pediatric Instatrak Systemcites it directly · 1998
K983529 Instatrak 3000cites it directly · 1998
K990919 Straight Aspirator, 90 Degree Aspirator,45…cites it directly · 1999
K982994 Skull Base Instatrak Systemcites it directly · 1998

Most influential descendants

Showing 5 of 328 · See all

K981998Pediatric Instatrak SystemVisualization Technology, Inc. · 1998 · cites it directly327descendants
K983529Instatrak 3000Visualization Technology, Inc. · 1998 · cites it directly325descendants
K994270Instatrak 3000 System with Fluorotrak Module, Model IT3000Visualization Technology, Inc. · 2000 · 2 generations on294descendants
K982994Skull Base Instatrak SystemVisualization Technology, Inc. · 1998 · cites it directly280descendants
K053610AbarisTraxtal Technologies, Inc. · 2006 · cites it directly278descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K960330	Instatrak	Visualization Technology, Inc.	1996	—
+1	K981998	Pediatric Instatrak System	Visualization Technology, Inc.	1998	Class I
+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	K982994	Skull Base Instatrak System	Visualization Technology, Inc.	1998	Class I
+1	K053610	Abaris	Traxtal Technologies, Inc.	2006	3

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	3	3
1999	1	1
2000	1	1
2002	1	1
2004	1	0
2006	3	0
2008	2	0
2009	2	0
2010	2	0
2011	2	0
2012	6	0
2013	4	0
2014	12	0
2015	18	0
2016	23	0
2017	34	0
2018	22	0
2019	17	0
2020	35	0
2021	26	0
2022	24	0
2023	19	0
2024	19	0
2025	28	2
2026	23	0

FIG. 1 — Lineage of K960330, 1996–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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.

9 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 LLZ device

#1 K230955 syngo Application Softwarescore 21.5 · 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? (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	Applicant	Decided	Recalls
*	—	Viewing Wand Named without a submission number			—
*	—	Barnes Suction Tube Named without a submission number			—

What descends from it? (328)

See all 328

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

Number	Device	Applicant	Decided	Descendants
K981998	Pediatric Instatrak System Class I	Visualization Technology, Inc.	1998	327
K983529	Instatrak 3000 Class I	Visualization Technology, Inc.	1998	325
K982994	Skull Base Instatrak System Class I	Visualization Technology, Inc.	1998	280
K053610	Abaris	Traxtal Technologies, Inc.	2006	278
K133573	Fiagon Navigation System	Fiagon GmbH	2014	28
K141456	The Fiagon Navigation - Extended Instrument Set Ent, Registrationpointer…	Fiagon GmbH	2014	13
K060906	Calypso 4D Localization System	Calypso Medical Technologies, Inc.	2006	11
K990919	Straight Aspirator, 90 Degree Aspirator,45 Degree Aspirator,7 French Aspirator,Extended… Class I	Visualization Technology, Inc.	1999	0

Has anything in its family been recalled? (9 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Nov 26, 2013	Class II	Z-0524-2014	Software Design Change	GE OEC Medical Systems Inc is recalling InstaTrak 3500 Plus, ENTrakTM Plus, InstaTrak 3500, ENTrakTM Computer-Assisted Navigation Systems (USA) due to several potential safety issues related to the use of these products.
Jun 22, 2009	Class I	Z-2251-2012	Labeling False and Misleading	GE Healthcare Surgery had discovered that using the Inverted Headset Placement is not a validated configuration with the IT 3000, 2500, 2500 plus, 3500, 3500 plus, ConneCTstat, and ConneCTstat Plus Surgical Navigation equipment.
Oct 18, 2007	Not classified	Z-0183-2008	Device Design	Crack, Fracture or Detachment: The Transmitter Arm for the Mayfield-compatible Transmitter may become detached from the unit and enter into the surgical field.
May 18, 2007	Not classified	Z-1130-2007	Other	Cleaning probes used to unclog disposable aspirators may shed small particles of nylon material which may be transferred into the nasal cavity.
Dec 13, 2004	Not classified	Z-0687-05	Other	Enhanced sterility testing revealed the sterilization efficacy of accessories ('Sensors') used with certain Navigation and Visualization systems may be compromised.
Dec 13, 2004	Not classified	Z-0688-05	Other	Enhanced sterility testing revealed the sterilization efficacy of accessories ('Sensors') used with certain Navigation and Visualization systems may be compromised.
Jul 12, 2004	Not classified	Z-0813-05	Other	Navigation inaccuracy may result if the headset registration method is used with the Axcess System Kit.
Jul 12, 2004	Not classified	Z-0812-05	Other	Navigation inaccuracy may result if the headset registration method is used with the Axcess System Kit.
Jul 12, 2004	Not classified	Z-0814-05	Other	Navigation inaccuracy may result if the headset registration method is used with the Axcess System Kit.

The 5 latest of 9 recalls; the web page lists all.

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.

K981998Pediatric Instatrak SystemVisualization Technology, Inc. · 1998 · Cites it directly · ◆ in the 1998 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
K990919Straight Aspirator, 90 Degree Aspirator,45 Degree Aspirator,7 French Aspirator,Extended Straight…Visualization Technology, Inc. · 1999 · Cites it directly · ◆ in the 1999 descendants bar of FIG. 11 Class I recall
K982994Skull Base Instatrak SystemVisualization 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
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 8; all are on the web page.

What does this lineage say?

Of its descendants, K981998 (Visualization Technology, Inc., 1998) has gone furthest, with 327 descendants of its own.

How does its category compare?

All LLZ devices

LLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LLZ

58in 2025

2007high 106 (2011) · low 51 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LLZ

173in 2025

2007high 173 (2025) · low 36 (2007)2026

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

Recalls per year · LLZ

11in 2025

2007high 64 (2013) · low 2 (2019)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LLZ

116in 2025

2007high 15,631 (2014) · low 26 (2023)2025

MAUDE reports naming product code LLZ, 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	76	36	20	152
2008	94	52	32	154
2009	70	62	21	145
2010	51	98	17	145
2011	106	79	30	454
2012	82	87	12	266
2013	95	84	64	1,130
2014	78	89	6	15,631
2015	64	90	16	211
2016	82	90	12	290
2017	78	107	5	104
2018	104	105	7	72
2019	74	107	2	88
2020	81	115	6	82
2021	83	116	3	70
2022	65	137	4	28
2023	87	157	8	26
2024	62	131	6	42
2025	58	173	11	116
2026	45	110	14	—

What is it indicated for?

Intranasal or sinuses

Acute and chronic sinusitis, endoscopic dacryocystorhinostomy, optic nerve and orbital decompression, the removal of polyps, the biopsy and removal of tumors, and the repair of CSF leaks, pituitary disorder, and encephalocele

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K960330 · printed Nov 6, 2026

Cite this page

510(k) Report. “K960330: Instatrak.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K960330

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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