510(k) Report

510(k) · Cleared

Recalled · Class II · 2015

CRW-1 System

K944463510(k) TraditionalCleared Oct 26, 1995409-day reviewClass II21 CFR 882.4560Recalls 4

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Radionics Software Applications, Inc. · HAW Neurological Stereotaxic Instrument

Cleared on Oct 26, 1995 after a 409-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 20 later devices descend from it. It has been recalled 4 times.

Decided
Oct 26, 1995
Review
409 days
Class
Class II
Product code
HAW
Recalls
4
Predicates
0

20 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2016: 1 descendant cleared1996: 1 descendant cleared2000: 1 descendant cleared2004: 3 descendants cleared2009: 1 descendant cleared2017: 3 descendants cleared2006: 1 descendant cleared2025: 1 descendant cleared2023: 2 descendants cleared2021: 3 descendants cleared2022: 2 descendants cleared2026: 1 descendant cleared1995200020052010201520202025
  1. This deviceK944463 CRW-1 SystemRadionics Software Applications, Inc. · 1995
  2. Descendant · cites it directly · 18 of its ownK961858 Cosgrove Depth Electrode Kit (Cdek)Radionics, Inc. · 1996
  3. Descendant · 2 generations on · 17 of its ownK991522 Microtargeting ElectrodeFHC, Inc. · 2000 · Recalled
  4. Descendant · 2 generations on · 16 of its ownK033173 Micro Targeting ElectrodeFHC, Inc. · 2004
  5. Descendant · 3 generations on · 12 of its ownK041604 Macro-Micro Depth ElectrodeAd-Tech Medical Instrument Corp · 2004
  6. Descendant · 4 generations on · 11 of its ownK053358 Depth Electrode, Foramen Ovale Depth Electrodes, Wyler Sphenoidal…Ad-Tech Medical Instrument Corp · 2006

Showing 5 of 20 descendants. See all descendants

Descendants cleared per year

1996: 12000: 12004: 32006: 12009: 12016: 12017: 32021: 32022: 22023: 22025: 12026: 1
1996high 3 (2004) · low 0 (1997)2026

Most influential descendants

Showing 5 of 20 · See all
  • K961858Cosgrove Depth Electrode Kit (Cdek)Radionics, Inc. · 1996 · cites it directly18descendants
  • K991522Microtargeting ElectrodeFHC, Inc. · 2000 · 2 generations on17descendants
  • K033173Micro Targeting ElectrodeFHC, Inc. · 2004 · 2 generations on16descendants
  • K041604Macro-Micro Depth ElectrodeAd-Tech Medical Instrument Corp · 2004 · 3 generations on12descendants
  • K053358Depth Electrode, Foramen Ovale Depth Electrodes, Wyler Sphenoidal Depth ElectrodesAd-Tech Medical Instrument Corp · 2006 · 4 generations on11descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K944463CRW-1 SystemRadionics Software Applications, Inc.1995—
+1K961858Cosgrove Depth Electrode Kit (Cdek)Radionics, Inc.1996—
+2K991522Microtargeting ElectrodeFHC, Inc.20003
+2K033173Micro Targeting ElectrodeFHC, Inc.2004—
+3K041604Macro-Micro Depth ElectrodeAd-Tech Medical Instrument Corp2004—
+4K053358Depth Electrode, Foramen Ovale Depth Electrodes, Wyler Sphenoidal Depth…Ad-Tech Medical Instrument Corp2006—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
200010
200430
200610
200910
201610
201730
202130
202220
202320
202510
202610
FIG. 1 — Lineage of K944463, 1995–2026Source: 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
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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? (20)

See all 20

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K961858Cosgrove Depth Electrode Kit (Cdek)Radionics, Inc.199618
K160811CRW Stereotactic SystemIntegra LifeSciences Corporation20160

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Aug 21, 2015Class IIZ-0025-2016Process designIntegra identified that the UCHRAP component (Arc Adapter Plate) would not assemble properly to the UCHRAR component (ARC Adapter Ring) of the Compact Head Ring Adapter due to an error in the manufacturing drawing.
Aug 9, 2012Class IIZ-2428-2012Device DesignT-handle screw is used on a complementary product to the CRW, the Integra HRAIM, which is the CT-compatible intubation Head Ring Assembly. When the T-handle on the HRAIM intubation hoop is tightened, the T-handle could stop in a vertical…
Aug 9, 2012Class IIZ-2429-2012Device DesignT-handle screw is used on a complementary product to the CRW, the Integra HRAIM, which is the CT-compatible intubation Head Ring Assembly. When the T-handle on the HRAIM intubation hoop is tightened, the T-handle could stop in a vertical…
Jan 12, 2011Not classifiedZ-1400-2011Manufacturing material removalOverall length of the intubation hoop in the HRAIM Intubation Head Ring Assembly is too long and will not allow a device to to attach

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K961858 (Radionics, Inc., 1996) has gone furthest, with 18 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 Radionics Software Applications, Inc.

12 FDA decisions under this applicant name. See the company

  • K990326Optical Tracking System Microscope Module II, Model Ots MmiiRadionics Software Applications, Inc. · 1999
  • K974602Optical Tracking System (Ots)Radionics Software Applications, Inc. · 1998
  • K972905XPLAN-1Radionics Software Applications, Inc. · 1997
  • K964801Optical Tracking System (Ots)Radionics Software Applications, Inc. · 1997
  • K961844Operating Arm System (Oas) [with CT and MR Images]Radionics Software Applications, Inc. · 1996

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/K944463 · printed Nov 4, 2026

Cite this page

510(k) Report. “K944463: CRW-1 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K944463

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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