510(k) · Cleared
ClearedMayfield/Acciss Operating Arm System and Mayfield/Optical Acciss System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ohio Medical Instrument Co., Inc. · HAW Neurological Stereotaxic Instrument
Cleared on Apr 4, 2002 as substantially equivalent to K981686 (Surgical Navigation Technologies, Inc., 1998) and 3 other predicates after a 170-day review. Its family tree reaches back 2 generations to 1996. 1 later device descends from it.
- Decided
- Apr 4, 2002
- Review
- 170 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K954276 (1996). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK954276 StealthstationSurgical Navigation Technologies, Inc. · 1996 · Recalled
- 1 generation backK981686 Stealthstation System Digitizer ChangeSurgical Navigation Technologies, Inc. · 1998
- This deviceK013428 Mayfield/Acciss Operating Arm System and Mayfield/Optical Acciss…Ohio Medical Instrument Co., Inc. · 2002
- Descendant · cites it directly · 0 of its ownK041897 Mayfield Acciss II Image Guided Surgery System, Model 2002-01Schaerer Mayfield USA, Inc. · 2005
Most influential descendants
Showing 1 of 1 · See all- K041897Mayfield Acciss II Image Guided Surgery System, Model 2002-01Schaerer Mayfield USA, Inc. · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K954276 | Stealthstation | Surgical Navigation Technologies, Inc. | 1996 | 1 |
| −1 | K981686 | Stealthstation System Digitizer Change | Surgical Navigation Technologies, Inc. | 1998 | — |
| 0 (this device) | K013428 | Mayfield/Acciss Operating Arm System and Mayfield/Optical Acciss System | Ohio Medical Instrument Co., Inc. | 2002 | — |
| +1 | K041897 | Mayfield Acciss II Image Guided Surgery System, Model 2002-01 | Schaerer Mayfield USA, Inc. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 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? (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 | Decided |
|---|---|---|---|
| * | K981686 | Stealthstation System Digitizer ChangeSummary page 1…6 MAYFIELD®/ACCISS™ Operating Arm System and MAYFIELD®IOpt|caI ACCISS™ System Computer-based Image-guided Stereotactic Planning System Instrument, Stereotaxic (84HAW) K981686 StealthStation® System, K003699 Medivision IGS System K001153 StealthStatlon Generation 3 System K005389 VectorVision® Page 1 o… | 1998 |
| * | K003699 | Medivision Igs SystemSummary page 1…rm System and MAYFIELD®IOpt|caI ACCISS™ System Computer-based Image-guided Stereotactic Planning System Instrument, Stereotaxic (84HAW) K981686 StealthStation® System, K003699 Medivision IGS System K001153 StealthStatlon Generation 3 System K005389 VectorVision® Page 1 of 2 JCoj3 a2 De… | 2001 |
| * | K001153 | Modification to Steathstation Treatment Guidance PlatformSummary page 1…ACCISS™ System Computer-based Image-guided Stereotactic Planning System Instrument, Stereotaxic (84HAW) K981686 StealthStation® System, K003699 Medivision IGS System K001153 StealthStatlon Generation 3 System K005389 VectorVision® Page 1 of 2 JCoj3 a2 Device Description: The devices a… | 2000 |
| * | K003589 | Vectorvision Cranial, Vectorvision Spinal, Vectorvision Ent Our OCR of the scanned summary read K005389, which is not a number in FDA’s lists. Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “VectorVision®”. | 2001 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K041897 | Mayfield Acciss II Image Guided Surgery System, Model 2002-01 | 2005 | 0 |
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?
- The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 3.7 years on median.
- 2 of the 5 ancestors have a recall of any class.
- Of its descendants, K041897 (Schaerer Mayfield USA, Inc., 2005) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K981686.
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 MAYFIELD®/ACCISS™ Operating Arm System and the MAYFIELD®/Optical ACCISS™ System are indicated for open and percutaneous procedures for any medical condition where reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra, or previously placed fiducial markers, can be identified relative to a CT or MRI and the use of stereotactic surgery may be considered appropriate.
Representative uses would be for cranial, spinal and ENT 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/K013428 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013428: Mayfield/Acciss Operating Arm System and Mayfield/Optical Acciss System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013428
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026