510(k) · Cleared
ClearedViewpoint
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems (Cleveland), Inc. · GAW Suture, Nonabsorbable, Synthetic, Polypropylene
Cleared on May 16, 1996 as substantially equivalent to K911783 (I.S.G. Technologies, Inc., 1994) and 2 other predicates after a 52-day review. Its family tree reaches back 1 generation to 1991. 161 later devices descend from it.
- Decided
- May 16, 1996
- Review
- 52 days
- Class
- Class II
- Product code
- GAW
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K905070 (1991). 3 ancestors in all. 161 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK905070 VistarPhilips Medical Systems (Cleveland), Inc. · 1991
- This deviceK961168 ViewpointPhilips Medical Systems (Cleveland), Inc. · 1996
- Descendant · cites it directly · 160 of its ownK963221 Optical Digitizer Option for View PointPhilips Medical Systems (Cleveland), Inc. · 1997
- Descendant · cites it directly · 159 of its ownK970604 Viewpoint - 3.0 SoftwarePhilips Medical Systems (Cleveland), Inc. · 1997
- Descendant · 2 generations on · 152 of its ownK984298 Z Kat Flurotactic Guidance System MkiZ-Kat, Inc. · 1999
- Descendant · 3 generations on · 151 of its ownK013025 Modification to Flourolab PlusZ-Kat, Inc. · 2001
- Descendant · 4 generations on · 146 of its ownK031454 Acumen Surgical Navigation SystemBiomet, Inc. · 2004
Showing 5 of 161 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 161 · See all- K963221Optical Digitizer Option for View PointPhilips Medical Systems (Cleveland), Inc. · 1997 · cites it directly160descendants
- K970604Viewpoint - 3.0 SoftwarePhilips Medical Systems (Cleveland), Inc. · 1997 · cites it directly159descendants
- K984298Z Kat Flurotactic Guidance System MkiZ-Kat, Inc. · 1999 · 2 generations on152descendants
- K013025Modification to Flourolab PlusZ-Kat, Inc. · 2001 · 3 generations on151descendants
- K031454Acumen Surgical Navigation SystemBiomet, Inc. · 2004 · 4 generations on146descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K905070 | Vistar | Philips Medical Systems (Cleveland), Inc. | 1991 | — |
| 0 (this device) | K961168 | Viewpoint | Philips Medical Systems (Cleveland), Inc. | 1996 | — |
| +1 | K963221 | Optical Digitizer Option for View Point | Philips Medical Systems (Cleveland), Inc. | 1997 | — |
| +1 | K970604 | Viewpoint - 3.0 Software | Philips Medical Systems (Cleveland), Inc. | 1997 | — |
| +2 | K984298 | Z Kat Flurotactic Guidance System Mki | Z-Kat, Inc. | 1999 | — |
| +3 | K013025 | Modification to Flourolab Plus | Z-Kat, Inc. | 2001 | — |
| +4 | K031454 | Acumen Surgical Navigation System | Biomet, Inc. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 6 | 0 |
| 2001 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2012 | 4 | 0 |
| 2013 | 3 | 0 |
| 2014 | 2 | 0 |
| 2015 | 6 | 0 |
| 2016 | 5 | 0 |
| 2017 | 11 | 0 |
| 2018 | 2 | 0 |
| 2019 | 10 | 0 |
| 2020 | 12 | 0 |
| 2021 | 9 | 0 |
| 2022 | 14 | 0 |
| 2023 | 20 | 0 |
| 2024 | 14 | 0 |
| 2025 | 18 | 0 |
| 2026 | 11 | 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 GAW? 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 GAW device
- #1 K253572 STRATAFIX™ Spiral PRONOVA™ Unidirectional…score 14.4 · 12 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 |
|---|---|---|---|
| * | K911783 | Allegro Viewing WandSummary page 1…ilar to that of frame- stereotaxy without the limitations of frame-application. Safety and Effectiveness The ViewPoint is substantially equivalent to the Viewing Wand (K911783), the StealthStation (K954276) and the ViStar workstation (K905070) in safety and effectiveness. The following chart has been co… | 1994 |
| * | K954276 | StealthstationSummary page 1…axy without the limitations of frame-application. Safety and Effectiveness The ViewPoint is substantially equivalent to the Viewing Wand (K911783), the StealthStation (K954276) and the ViStar workstation (K905070) in safety and effectiveness. The following chart has been compiled to demonstrate ViewPoin… | 1996 |
| * | K905070 | VistarSummary page 1…application. Safety and Effectiveness The ViewPoint is substantially equivalent to the Viewing Wand (K911783), the StealthStation (K954276) and the ViStar workstation (K905070) in safety and effectiveness. The following chart has been compiled to demonstrate ViewPoint’s substantial equivalence to these… | 1991 |
What descends from it? (161)
See all 1612 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All GAW devicesGAW Suture, Nonabsorbable, Synthetic, Polypropylene: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GAW
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · GAW
80in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GAW
2so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GAW
2,545in 2025
MAUDE reports naming product code GAW, 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 | 1 | — | 1 | 73 |
| 2008 | 0 | — | 0 | 75 |
| 2009 | 0 | — | 0 | 71 |
| 2010 | 2 | — | 0 | 85 |
| 2011 | 0 | — | 0 | 84 |
| 2012 | 3 | 86 | 0 | 194 |
| 2013 | 3 | 36 | 0 | 191 |
| 2014 | 2 | — | 0 | 437 |
| 2015 | 3 | 252 | 0 | 422 |
| 2016 | 1 | — | 0 | 440 |
| 2017 | 3 | 145 | 0 | 413 |
| 2018 | 3 | 80 | 0 | 685 |
| 2019 | 1 | — | 0 | 1,803 |
| 2020 | 2 | — | 0 | 1,493 |
| 2021 | 0 | — | 0 | 1,652 |
| 2022 | 2 | — | 0 | 1,563 |
| 2023 | 1 | — | 0 | 1,811 |
| 2024 | 1 | — | 0 | 2,348 |
| 2025 | 0 | — | 0 | 2,545 |
| 2026 | 1 | — | 2 | — |
What is it indicated for?
The ViewPoint is intended for use as a device which uses diagnostic images of the patient acquired specifically to assist the physician with presurgical planning and to provide orientation and reference information during intra-cranial surgical procedures involving space occupying lesions or malformations (including soft tissue, vascular and osseous).
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/K961168 · printed Nov 6, 2026
Cite this page
510(k) Report. “K961168: Viewpoint.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K961168
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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