510(k) · Cleared

Recalled · Class I · 2009

Straight Aspirator, 90 Degree Aspirator,45 Degree Aspirator,7 French Aspirator,Extended Straight Aspirator,13.9 CM Strag

K990919510(k) SpecialCleared Apr 15, 199928-day reviewClass II21 CFR 892.2050Recalls 1 (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 15, 1999 as substantially equivalent to K960330 (Visualization Technology, Inc., 1996) and 3 other predicates after a 28-day review. Its family tree reaches back 3 generations to 1994. 5 of the 7 devices in its family, counting itself, have a Class I recall. It has been recalled once, including a Class I recall.

Decided: Apr 15, 1999
Review: 28 days
Class: Class II
Product code: LLZ
Recalls: 1 (1 Class I)
Predicates: 4

Its longest line of descent runs back 3 generations to K911783 (1994). 6 ancestors in all. No later device cites it as a predicate yet. 5 of the 7 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 3 generations backK911783 Allegro Viewing WandI.S.G. Technologies, Inc. · 1994
2 generations backK981998 Pediatric Instatrak SystemVisualization Technology, Inc. · 1998 · Recalled (Class I)
1 generation backK982994 Skull Base Instatrak SystemVisualization Technology, Inc. · 1998 · Recalled (Class I)
This deviceK990919 Straight Aspirator, 90 Degree Aspirator,45 Degree Aspirator,7 French…Visualization Technology, Inc. · 1999

Class I recalls in this family

K983529 Instatrak 3000direct predicate · 1998
K982994 Skull Base Instatrak Systemdirect predicate · 1998
K981998 Pediatric Instatrak Systemdirect predicate · 1998
K960330 Instatrakdirect predicate · 1996

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K911783	Allegro Viewing Wand	I.S.G. Technologies, Inc.	1994	—
−2	K981998	Pediatric Instatrak System	Visualization Technology, Inc.	1998	Class I
−1	K982994	Skull Base Instatrak System	Visualization Technology, Inc.	1998	Class I
0 (this device)	K990919	Straight Aspirator, 90 Degree Aspirator,45 Degree Aspirator,7 French…	Visualization Technology, Inc.	1999	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1996	2	1
1998	1	1

FIG. 1 — Lineage of K990919, 1994–1999Source: 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.

5 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

Get a 510(k) Report

What was it cleared against? (4)

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
*	K960330	Instatrak Summary page 1 …pplied as accessories with the InstaTrak 3000 System. The aspirators and pointers have the same principle of operation, as those accessories described in the predicates, K960330, K981998, K982994, and K983529. Other than the non-sterile reusable labeling and a color change to a non-patient contact portion…	Visualization Technology, Inc.	1996	Class I
*	K981998	Pediatric Instatrak System Summary page 1 …accessories with the InstaTrak 3000 System. The aspirators and pointers have the same principle of operation, as those accessories described in the predicates, K960330, K981998, K982994, and K983529. Other than the non-sterile reusable labeling and a color change to a non-patient contact portion of the in…	Visualization Technology, Inc.	1998	Class I
*	K982994	Skull Base Instatrak System Summary page 1 …ies with the InstaTrak 3000 System. The aspirators and pointers have the same principle of operation, as those accessories described in the predicates, K960330, K981998, K982994, and K983529. Other than the non-sterile reusable labeling and a color change to a non-patient contact portion of the instrument…	Visualization Technology, Inc.	1998	Class I
*	K983529	Instatrak 3000 Summary page 1 …Degree Aspirator, 7 French Aspirator, Extended Straight Aspirator, 13.9 cm Straight Pointer, 4.7 cm Aspirator (Note: the above are all accessories of the InstaTrak 3000 K983529.) Common Name(s): Aspirators and pointers Classification Name: The aspirators and pointers are accessories of the InstaTrak 3000…	Visualization Technology, Inc.	1998	Class I

Also cleared against K960330: 7 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (5 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
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.

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.

K983529Instatrak 3000Visualization Technology, Inc. · 1998 · Direct predicate · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
K982994Skull Base Instatrak SystemVisualization Technology, Inc. · 1998 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
K981998Pediatric Instatrak SystemVisualization Technology, Inc. · 1998 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
K960330InstatrakVisualization Technology, Inc. · 1996 · Direct predicate · ◆ in the 1996 ancestors bar of FIG. 11 Class I recall

What does this lineage say?

The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 5 months on median.
5 of the 6 ancestors have a recall of any class; 4 have a Class I recall.
7 other devices also cite its predicate K960330.

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?

The aspirators and pointers are accessories of the previously cleared InstaTrak 3000 System, (K983529) and therefore have the same intended use.

The InstaTrak 3000 System is intended as an aid to the surgeon for precisely locating anatomical structures anywhere on the human body during either open or percutaneous procedures. It is indicated for any medical condition that may benefit from the use of stereotactic surgery and which provides a reference to rigid anatomical structures such as sinus, skull, cranial, a long bone or vertebra, visible on medical images such as CT or MR.

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/K990919 · printed Nov 4, 2026

Cite this page

510(k) Report. “K990919: Straight Aspirator, 90 Degree Aspirator,45 Degree Aspirator,7 French Aspirator,Extended Straight Aspirator,13.9 CM Strag.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K990919

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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