510(k) · Cleared

Cleared

Optical Tracking System Microscope Module II, Model Ots Mmii

K990326510(k) SpecialCleared Mar 4, 199930-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

Radionics Software Applications, Inc. · HAW Neurological Stereotaxic Instrument

Cleared on Mar 4, 1999 as substantially equivalent to K981213 (Radionics, Inc., 1998) and 1 other predicate after a 30-day review. Its family tree reaches back 1 generation to 1997.

Decided: Mar 4, 1999
Review: 30 days
Class: Class II
Product code: HAW
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K965139 (1997). 2 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK965139 Surgical Microscope Navigator (SMN) System/Surgical Tool Navigator…Carl Zeiss, Inc. · 1997
This deviceK990326 Optical Tracking System Microscope Module II, Model Ots MmiiRadionics Software Applications, Inc. · 1999

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K965139	Surgical Microscope Navigator (SMN) System/Surgical Tool Navigator (STN) System	Carl Zeiss, Inc.	1997	—
0 (this device)	K990326	Optical Tracking System Microscope Module II, Model Ots Mmii	Radionics Software Applications, Inc.	1999	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0

FIG. 1 — Lineage of K990326, 1997–1999Source: 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.

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? (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
*	K981213	Universal Instrument Registration (Uir) Microscope Module I Summary page 1 …its classification name is a Stereotaxic instrument (accessory). 3.0 The above device is substantial equivalent to the Radionics Microscope Module I cleared via 510(k) K981213 and Zeiss Surgical Microscope Navigator System cleared via 510(k) K965139. 4.0 The above device consists of a software module th…	Radionics, Inc.	1998	—
*	K965139	Surgical Microscope Navigator (SMN) System/Surgical Tool Navigator (STN) System Summary page 1 …above device is substantial equivalent to the Radionics Microscope Module I cleared via 510(k) K981213 and Zeiss Surgical Microscope Navigator System cleared via 510(k) K965139. 4.0 The above device consists of a software module that allows a variable focused microscope to be used with OTS. The position…	Carl Zeiss, Inc.	1997	—

What descends from it?

No later submission names this one as a predicate yet.

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?

None of the 2 ancestors has a recall.

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?

Interactive, image-guided means of localizing targets in surgical procedures. OTS is indicated for use in cranial and spinal surgical procedures in which anatomical landmarks are not clearly visible or where a desired target is close to critical structures.

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/K990326 · printed Nov 5, 2026

Cite this page

510(k) Report. “K990326: Optical Tracking System Microscope Module II, Model Ots Mmii.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K990326

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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