510(k) · Cleared
ClearedPhilips Easyguide
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems, Inc. · HAW Neurological Stereotaxic Instrument
Cleared on Oct 13, 1998 as substantially equivalent to K962939 (Brainlab, Inc., 1997) and 2 other predicates after a 224-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- Oct 13, 1998
- Review
- 224 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K954276 (1996). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK954276 StealthstationSurgical Navigation Technologies, Inc. · 1996 · Recalled
- This deviceK980820 Philips EasyguidePhilips Medical Systems, Inc. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K954276 | Stealthstation | Surgical Navigation Technologies, Inc. | 1996 | 1 |
| 0 (this device) | K980820 | Philips Easyguide | Philips Medical Systems, Inc. | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 2 | 0 |
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
What was it cleared against? (3)
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 | Decided |
|---|---|---|---|
| * | K962939 | VectorvisionSummary page 2…he Philips EasyGuide Standard Workstation with the Neuro (Release 2) option and the EasyTaxis option is considered substantially equivalent to the BrainLab VectorVision (K962939), the Zeiss Surgical Microscope Navigator (SMN) (K965139) and the Sofamor Danek StealthStation (K954276). A comparison matrix is… | 1997 |
| * | K965139 | Surgical Microscope Navigator (SMN) System/Surgical Tool Navigator (STN) SystemSummary page 2…(Release 2) option and the EasyTaxis option is considered substantially equivalent to the BrainLab VectorVision (K962939), the Zeiss Surgical Microscope Navigator (SMN) (K965139) and the Sofamor Danek StealthStation (K954276). A comparison matrix is provided in Appendix 5 along with commercial brochures fo… | 1997 |
| * | K954276 | StealthstationSummary page 2…considered substantially equivalent to the BrainLab VectorVision (K962939), the Zeiss Surgical Microscope Navigator (SMN) (K965139) and the Sofamor Danek StealthStation (K954276). A comparison matrix is provided in Appendix 5 along with commercial brochures for the predicate devices. SAFETY INFORMATION: T… | 1996 |
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?
- 1 of the 3 ancestors has a recall of any class.
- 1 other device also cites its predicate K962939.
How does its category compare?
All HAW devicesHAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HAW
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HAW
163in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HAW
2in 2025
Class I (9 since 2007) Class II/III not classified
Adverse event reports per year · HAW
3,425in 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?
The EasyGuide Neuro (Release 2) option is used for instrument pointing, instrument learning, 3D marker visualization and image rendering when used with the EasyGuide Standard Workstation which is indicated for use in planning neurosurgical procedures and for localizing and navigating during neurosurgical procedures. The EasyTaxis option is used to assist the surgeon in the positioning of instruments and in guiding an instrument to its targeted position…
Read the full statement (124 words)
The EasyGuide Neuro (Release 2) option is used for instrument pointing, instrument learning, 3D marker visualization and image rendering when used with the EasyGuide Standard Workstation which is indicated for use in planning neurosurgical procedures and for localizing and navigating during neurosurgical procedures.
The EasyTaxis option is used to assist the surgeon in the positioning of instruments and in guiding an instrument to its targeted position during a surgical procedure when used with the EasyGuide Standard Workstation which is indicated for use in planning neurosurgical procedures and for localizing and navigating during neurosurgical procedures.
The Easyguide Neuro (Release 2) option and the EasyTaxis option are used for support in neurosurgical procedures such as:
Frameless stereotactic procedures
Intra-operative resection of brain tumors
Biopsies
Endoscopic procedures
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/K980820 · printed Nov 5, 2026
Cite this page
510(k) Report. “K980820: Philips Easyguide.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K980820
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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