510(k) Report

510(k) · Cleared

Cleared

Accufix Tilting Radiotranslucent Headholder

K021124510(k) TraditionalCleared Jul 2, 200285-day reviewClass II21 CFR 892.5050

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

Wfr/Aquaplast Corp. · IYE Accelerator, Linear, Medical

Cleared on Jul 2, 2002 after an 85-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 7 later devices descend from it.

Decided
Jul 2, 2002
Review
85 days
Class
Class II
Product code
IYE
Recalls
None
Predicates
0

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

Descendants, by year cleared 2005: 1 descendant cleared2013: 1 descendant cleared2018: 1 descendant cleared2016: 1 descendant cleared2017: 1 descendant cleared2021: 1 descendant cleared2023: 1 descendant cleared200020052010201520202025
  1. This deviceK021124 Accufix Tilting Radiotranslucent HeadholderWfr/Aquaplast Corp. · 2002
  2. Descendant · cites it directly · 6 of its ownK050701 Thigh and Foot Positioner, Suprone Plus, Model RT-6010Bionix Development Corp. · 2005
  3. Descendant · 2 generations on · 5 of its ownK122888 CDR Systems Precision Patient Positioning SystemCdr Systems, Inc. · 2013
  4. Descendant · 3 generations on · 3 of its ownK153026 Body Pro-Lok Respiratory Plate, Respiratory Plate Cushion, Body…Medtec, Inc. D/B/A Civco Medical Solutions · 2016
  5. Descendant · 4 generations on · 1 of its ownK210894 Siddharth-II; ImpactPanacea Medical Technologies Pvt., Ltd. · 2021
  6. Descendant · 5 generations on · 0 of its ownK222762 Siddharth-II;ImpactPanacea Medical Technologies Pvt., Ltd. · 2023

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2005: 12013: 12016: 12017: 12018: 12021: 12023: 1
2005high 1 (2005) · low 0 (2006)2026

Most influential descendants

Showing 5 of 7 · See all
  • K050701Thigh and Foot Positioner, Suprone Plus, Model RT-6010Bionix Development Corp. · 2005 · cites it directly6descendants
  • K122888CDR Systems Precision Patient Positioning SystemCdr Systems, Inc. · 2013 · 2 generations on5descendants
  • K153026Body Pro-Lok Respiratory Plate, Respiratory Plate Cushion, Body Pro-Respiratory Belt…Medtec, Inc. D/B/A Civco Medical Solutions · 2016 · 3 generations on3descendants
  • K210894Siddharth-II; ImpactPanacea Medical Technologies Pvt., Ltd. · 2021 · 4 generations on1descendant
  • K222762Siddharth-II;ImpactPanacea Medical Technologies Pvt., Ltd. · 2023 · 5 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K021124Accufix Tilting Radiotranslucent HeadholderWfr/Aquaplast Corp.2002—
+1K050701Thigh and Foot Positioner, Suprone Plus, Model RT-6010Bionix Development Corp.2005—
+2K122888CDR Systems Precision Patient Positioning SystemCdr Systems, Inc.2013—
+3K153026Body Pro-Lok Respiratory Plate, Respiratory Plate Cushion, Body…Medtec, Inc. D/B/A Civco Medical Solutions2016—
+4K210894Siddharth-II; ImpactPanacea Medical Technologies Pvt., Ltd.2021—
+5K222762Siddharth-II;ImpactPanacea Medical Technologies Pvt., Ltd.2023—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
201310
201610
201710
201810
202110
202310
FIG. 1 — Lineage of K021124, 2002–2023Source: 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), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in IYE? 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 IYE device

  1. #1 K252977 Halcyon, Ethos Radiotherapy System (5.0)score 18.8 · 18 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’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (7)

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

NumberDeviceApplicantDecidedDescendants
K050701Thigh and Foot Positioner, Suprone Plus, Model RT-6010Bionix Development Corp.20056

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, K050701 (Bionix Development Corp., 2005) has gone furthest, with 6 descendants of its own.

How does its category compare?

All IYE devices

IYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IYE

12in 2025

2007: 232008: 142009: 202010: 232011: 112012: 282013: 182014: 202015: 202016: 212017: 232018: 212019: 192020: 202021: 192022: 122023: 182024: 92025: 122026 (partial year): 14
2007high 28 (2012) · low 9 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IYE

170in 2025

2007: 44 days median2008: 69 days median2009: 63 days median2010: 74 days median2011: 94 days median2012: 106 days median2013: 88 days median2014: 100 days median2015: 108 days median2016: 97 days median2017: 94 days median2018: 58 days median2019: 83 days median2020: 67 days median2021: 86 days median2022: 172 days median2023: 129 days median2024: 239 days median2025: 170 days median2026 (partial year): 120 days median
2007high 239 (2024) · low 44 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · IYE

1in 2025

2007: 782008: 492009: 222010: 272011: 732012: 202013: 112014: 142015: 82016: 72017: 72018: 72019: 22020: 42021: 52022: 32023: 72024: 12025: 12026 (partial year): 4
2007high 78 (2007) · low 1 (2024)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · IYE

101in 2025

2007: 1552008: 1142009: 1742010: 2462011: 2802012: 1282013: 962014: 1242015: 1002016: 972017: 1252018: 852019: 912020: 742021: 682022: 662023: 1282024: 812025: 101
2007high 280 (2011) · low 66 (2022)2025

MAUDE reports naming product code IYE, 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
2007234478155
2008146949114
2009206322174
2010237427246
2011119473280
20122810620128
201318881196
20142010014124
2015201088100
20162197797
201723947125
20182158785
20191983291
20202067474
20211986568
202212172366
2023181297128
20249239181
2025121701101
2026141204—

What is it indicated for?

The AccuFix Tilting Radiotranslucent Headholder is designed to be used with a head rest or prone pillow and Aquaplast RT Thermoplastic (IC: 935067) masks to immobilize and reposition patients undergoing radiation therapy on a linear accelerator treatment table. The AccuFix Headholder attaches to the treatment table, a Silverman brand head rest (for supine treatment) or prone pillow (for prone treatment) is attached to the headholder and a custom fit mask attaches to the headholder in such a way that patient head movement is minimized and the patient's head can be accurately repositioned for subsequent use.

Indications for use as stated in the FDA 510(k) statement.

More from Wfr/Aquaplast Corp.

8 FDA decisions under this applicant name. See the company

  • K120916Qfix Radiotherapy ChairWfr/Aquaplast Corp. · 2012
  • K060671Kvue Igrt Treatment Table Top, RT-4551KV, Kvue Inserts and Accessories, VariousWfr/Aquaplast Corp. · 2006
  • K032156Accufix Radiolucent Pelvis and Belly Boards, Accufix Cantilever Head Board with Shoulder Depression, Accufix…Wfr/Aquaplast Corp. · 2003
  • K973370Aquaplast Palatal StentWfr/Aquaplast Corp. · 1997
  • K943871Aquaplast Tie Down DressingWfr/Aquaplast Corp. · 1994

Recent decisions in IYE

The IYE category page

  • K261865AerFrame™ Alignment Laser Box (LBV2)Stabilix, LLC · 2026
  • K261718EZFluence (RADEZ V2)Radformation, Inc. · 2026
  • K260733MRIA Radiation Therapy Information System (MRIA)Manteia Technologies Co., Ltd. · 2026
  • K261856Halcyon, Ethos Radiotherapy System (5.0)Varian Medical Systems, Inc. · 2026
  • K252937ThinkQA 3Dosisoft SA · 2026

https://510kreport.com/device/K021124 · printed Nov 3, 2026

Cite this page

510(k) Report. “K021124: Accufix Tilting Radiotranslucent Headholder.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K021124

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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