510(k) · Cleared
ClearedMayfield Acciss Optical 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 Sep 23, 1998 as substantially equivalent to K955397 (Nomos Corp., 1996) and 1 other predicate after a 90-day review. Its family tree reaches back 2 generations to 1985. 2 later devices descend from it.
- Decided
- Sep 23, 1998
- Review
- 90 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K851659 (1985). 5 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK851659 Skull Mounted Stereotactic Surgical DeviceMedco Products, Co., Inc. · 1985
- 1 generation backK955397 Mayfield-Acciss WorkstationNomos Corp. · 1996
- This deviceK982244 Mayfield Acciss Optical SystemOhio Medical Instrument Co., Inc. · 1998
- Descendant · cites it directly · 0 of its ownK992843 The Mayfield / Acciss System with Windows NT for Cranial Surgery…Ohio Medical Instrument Co., Inc. · 1999
- Descendant · cites it directly · 0 of its ownK991267 Spine Applications for the Mayfield/Acciss Operating Arm and Optical…Ohio Medical Instrument Co., Inc. · 1999
Most influential descendants
Showing 2 of 2 · See all- K992843The Mayfield / Acciss System with Windows NT for Cranial Surgery, the Mayfield / Optical…Ohio Medical Instrument Co., Inc. · 1999 · cites it directly0descendants
- K991267Spine Applications for the Mayfield/Acciss Operating Arm and Optical Acciss Systems…Ohio Medical Instrument Co., Inc. · 1999 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K851659 | Skull Mounted Stereotactic Surgical Device | Medco Products, Co., Inc. | 1985 | — |
| −1 | K955397 | Mayfield-Acciss Workstation | Nomos Corp. | 1996 | — |
| 0 (this device) | K982244 | Mayfield Acciss Optical System | Ohio Medical Instrument Co., Inc. | 1998 | — |
| +1 | K992843 | The Mayfield / Acciss System with Windows NT for Cranial Surgery, the Mayfield… | Ohio Medical Instrument Co., Inc. | 1999 | — |
| +1 | K991267 | Spine Applications for the Mayfield/Acciss Operating Arm and Optical Acciss… | Ohio Medical Instrument Co., Inc. | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 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? (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 | Decided |
|---|---|---|---|
| * | K955397 | Mayfield-Acciss WorkstationSummary page 1…Affairs Director Ohio Medical Instrument Company, Inc. (OMI) 4900 Charlemar Drive Cincinnati, Ohio 45227 2. Name of predicate device(s): Mayfield® ACCISS™ Workstation (K955397) Pelorus Arc Carrier (K874833) 3. Classification: Neurosurgical stereotactic instruments and accessories are Class II (21CFR 88… | 1996 |
| * | K874833 | Arc Adapter AssemblySummary page 1…Instrument Company, Inc. (OMI) 4900 Charlemar Drive Cincinnati, Ohio 45227 2. Name of predicate device(s): Mayfield® ACCISS™ Workstation (K955397) Pelorus Arc Carrier (K874833) 3. Classification: Neurosurgical stereotactic instruments and accessories are Class II (21CFR 882.4800). 4, Performance Stand… | 1988 |
What descends from it? (2)
2 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?
- The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 10.8 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K992843 (Ohio Medical Instrument Co., Inc., 1999) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K955397.
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?
Intended Use: The Optical Tracking ACCISS™ System is intended to be used in an identical manner as the predicate device (Mayfield®/ ACCISS™ Stereotactic Workstation). It is used for guidance and localization in open craniotomies and for surgeries, which are traditionally performed with a stereotactic apparatus, such as biopsies, thalamotomies and electrode implants. The system may also be used to review medical images in a neurosurgical context.
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/K982244 · printed Nov 4, 2026
Cite this page
510(k) Report. “K982244: Mayfield Acciss Optical System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982244
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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