510(k) Report

510(k) · Cleared

Cleared

Skull Mounted Stereotactic Surgical Device

K851659510(k) TraditionalCleared Jul 1, 198569-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

Medco Products, Co., Inc. · HAW Neurological Stereotaxic Instrument

Cleared on Jul 1, 1985 after a 69-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 16 later devices descend from it.

Decided
Jul 1, 1985
Review
69 days
Class
Class II
Product code
HAW
Recalls
None
Predicates
0

16 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 1996: 1 descendant cleared1999: 3 descendants cleared1998: 2 descendants cleared2005: 2 descendants cleared2003: 1 descendant cleared2004: 1 descendant cleared2012: 2 descendants cleared2008: 1 descendant cleared2013: 1 descendant cleared2014: 2 descendants cleared1990200020102020
  1. This deviceK851659 Skull Mounted Stereotactic Surgical DeviceMedco Products, Co., Inc. · 1985
  2. Descendant · cites it directly · 15 of its ownK955397 Mayfield-Acciss WorkstationNomos Corp. · 1996
  3. Descendant · 2 generations on · 10 of its ownK981424 Nomos Bat Ultrasound Localization and Positioning SystemNomos Corp. · 1998
  4. Descendant · 3 generations on · 4 of its ownK032100 I-BEAMComputerized Medical Systems, Inc. · 2003
  5. Descendant · 3 generations on · 3 of its ownK042110 BeamcathBeampoint AB · 2005
  6. Descendant · 3 generations on · 3 of its ownK041937 RestituResonant Medical, Inc. · 2004

Showing 5 of 16 descendants. See all descendants

Descendants cleared per year

1996: 11998: 21999: 32003: 12004: 12005: 22008: 12012: 22013: 12014: 2
1996high 3 (1999) · low 0 (1997)2026

Most influential descendants

Showing 5 of 16 · See all
  • K955397Mayfield-Acciss WorkstationNomos Corp. · 1996 · cites it directly15descendants
  • K981424Nomos Bat Ultrasound Localization and Positioning SystemNomos Corp. · 1998 · 2 generations on10descendants
  • K032100I-BEAMComputerized Medical Systems, Inc. · 2003 · 3 generations on4descendants
  • K042110BeamcathBeampoint AB · 2005 · 3 generations on3descendants
  • K041937RestituResonant Medical, Inc. · 2004 · 3 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K851659Skull Mounted Stereotactic Surgical DeviceMedco Products, Co., Inc.1985—
+1K955397Mayfield-Acciss WorkstationNomos Corp.1996—
+2K981424Nomos Bat Ultrasound Localization and Positioning SystemNomos Corp.1998—
+3K032100I-BEAMComputerized Medical Systems, Inc.2003—
+3K042110BeamcathBeampoint AB2005—
+3K041937RestituResonant Medical, Inc.2004—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
199820
199930
200310
200410
200520
200810
201220
201310
201420
FIG. 1 — Lineage of K851659, 1985–2014Source: 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), 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
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (16)

See all 16

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K955397Mayfield-Acciss WorkstationNomos Corp.199615

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?

  • Of its descendants, K955397 (Nomos Corp., 1996) has gone furthest, with 15 descendants of its own.

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—

More from Medco Products, Co., Inc.

8 FDA decisions under this applicant name. See the company

  • K932466Medchem Surgical Delivery SystemMedco Products, Co., Inc. · 1993
  • K913172Endoscopic Delivery SystemMedco Products, Co., Inc. · 1991
  • K860099Medco-Sonic NQ-2000Medco Products, Co., Inc. · 1986
  • K852015Jyrochair, Model SK-HMedco Products, Co., Inc. · 1985
  • K844580Medcolator Model HVXMedco Products, Co., Inc. · 1985

Recent decisions in HAW

The HAW category page

  • K262214Disposable Reflective Marker Spheres (AM-BK115S, AM-BL130S)Guangzhou Aimooe Technology Co., Ltd. · 2026
  • K253856Geniant Cranial (Navigated Neurosurgical Positioning Robot)Koh Young Technology, Inc. · 2026
  • K261932Leksell® Vantage Stereotactic SystemElekta Solutions AB · 2026
  • K253663Zeta Navigation SystemZeta Surgical, Inc. · 2026
  • K253379Stealth AXiS Cranial clinical applicationMedtronic Navigation, Inc. · 2026

https://510kreport.com/device/K851659 · printed Nov 4, 2026

Cite this page

510(k) Report. “K851659: Skull Mounted Stereotactic Surgical Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K851659

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026