510(k) Report

510(k) · Cleared

Cleared

Magellan

K961903510(k) TraditionalCleared Aug 24, 1998830-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

Biosense, Ltd. · HAW Neurological Stereotaxic Instrument

Cleared on Aug 24, 1998 as substantially equivalent to K954395 (Biosense, Ltd., 1995) after an 830-day review. Its family tree reaches back 1 generation to 1995.

Decided
Aug 24, 1998
Review
830 days
Class
Class II
Product code
HAW
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K954395 (1995). No later device cites it as a predicate yet.

K954395 · Carto System · Biosense, Ltd. · 1995199619982000
K954395 · Carto System · Biosense, Ltd. · 19950
  1. Root · 1 generation backK954395 Carto SystemBiosense, Ltd. · 1995
  2. This deviceK961903 MagellanBiosense, Ltd. · 1998
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K954395Carto SystemBiosense, Ltd.1995—
0 (this device)K961903MagellanBiosense, Ltd.1998—
FIG. 1 — Lineage of K961903, 1995–1998Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K253856 Geniant Cranial (Navigated Neurosurgical…score 15.0 · 11 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against? (1)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K954395Carto System
Summary page 1
…omputer (per 21 CFR 870.1425) Common device name: Location system Legally marketed device to which ~ Biosense CARTO system substantial equivalence is being 510(k) No. K954395 claimed The Magellan system is a subset of the CARTO system. The CARTO system consists of the location system and the viewing s…
Biosense, Ltd.1995—

Also cleared against K954395: 3 other devices →

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?

  • Its one ancestor has no recall.
  • 3 other devices also cite its predicate K954395.

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

2007: 152008: 122009: 82010: 62011: 42012: 82013: 32014: 52015: 102016: 92017: 72018: 62019: 102020: 52021: 92022: 72023: 142024: 72025: 92026 (partial year): 5
2007high 15 (2007) · low 3 (2013)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HAW

163in 2025

2007: 107 days median2008: 112 days median2009: 221 days median2010: 138 days median2011: 66 days median2012: 178 days median2013: 172 days median2014: 238 days median2015: 232 days median2016: 175 days median2017: 226 days median2018: 112 days median2019: 147 days median2020: 88 days median2021: 168 days median2022: 128 days median2023: 142 days median2024: 107 days median2025: 163 days median2026 (partial year): 162 days median
2007high 238 (2014) · low 66 (2011)2026

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

Recalls per year · HAW

2in 2025

2007: 22008: 102009: 62010: 282011: 52012: 42013: 6, 1 Class I2014: 52015: 32016: 52017: 22018: 2, 2 Class I2019: 4, 1 Class I2020: 12021: 4, 2 Class I2022: 12023: 4, 1 Class I2024: 2, 2 Class I2025: 22026 (partial year): 6
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

2007: 492008: 532009: 962010: 2992011: 1,7252012: 9862013: 1,2902014: 1,6062015: 1,7672016: 1,8282017: 3,5052018: 4,4392019: 6,0622020: 3,4802021: 2,8272022: 1,9292023: 2,5102024: 3,7552025: 3,425
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200715107249
2008121121053
20098221696
2010613828299
201146651,725
201281784986
201331726 (1)1,290
2014523851,606
20151023231,767
2016917551,828
2017722623,505
201861122 (2)4,439
2019101474 (1)6,062
202058813,480
202191684 (2)2,827
2022712811,929
2023141424 (1)2,510
202471072 (2)3,755
2025916323,425
202651626—

What is it indicated for?

The MAGELLAN™ system, which is comprised of a medical workstation, 2 magnetic location system and a range of locatable tools is intended to be used as an image guided neurosurgery navigation system to pre-operatively and intra-operatively perform the following functions: process and display pre-aperatively radiographic images on & monitor; provide intra-operative image control based on the position and orientation of a user ditected tool; allow for the…

Read the full statement (244 words)

The MAGELLAN™ system, which is comprised of a medical workstation, 2 magnetic location system and a range of locatable tools is intended to be used as an image guided neurosurgery navigation system to pre-operatively and intra-operatively perform the following functions:

process and display pre-aperatively radiographic images on & monitor;

provide intra-operative image control based on the position and orientation of a user ditected tool;

allow for the integration and usage of the Blosense magnetic locatiou systcur and a range of different tool attachments; and

store/retrieve image data on computer access mediu (c.g. hard disks, archive media)

Circumstunces:

The MAGELLAN™ system is intended to be used during planning of a procedure, when more than one approach (c.g. cntry point, trajectory, craniotomy size) is being considercd, and also during surgery when:

the target or approach is in a region with few anatomical landmarks (e.g. subcortical brain) or with complex anatomy;

the target or approach is in a region where normal landmarks have been distorted either by disease or by previous surgery;

the target or approach is in close proximity to critical structures) e.g. venous sinuses, air sinuses, blood vessels, nerves) which must be avoided or negotialed, or

the target delineation is important and will not move significantly during the implementation of the approach (e.g. skull-based tumors. sinus diseascs, corpus callosotomies).

1Jisease or Conditions:

The MAGELLAN™ system is indicated for paticnts who have imaged space occupying lesions or malfunctions (Loth soft tissuc and osscous) in the head.

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

Cite this page

510(k) Report. “K961903: Magellan.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K961903

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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