510(k) Report

510(k) · Cleared

Cleared

Onedose Patient Dosimetry System

K040687510(k) TraditionalCleared Jun 25, 2004101-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

Sicel Technologies, Inc. · IYE Accelerator, Linear, Medical

Cleared on Jun 25, 2004 as substantially equivalent to K010472 (Thomson & Nielsen Electronics, Ltd., 2001) and 3 other predicates after a 101-day review. Its family tree reaches back 2 generations to 2001. 10 later devices descend from it.

Decided
Jun 25, 2004
Review
101 days
Class
Class II
Product code
IYE
Recalls
None
Predicates
4

Its longest line of descent runs back 2 generations to K011332 (2001). 4 ancestors in all, the oldest K010472 (2001). 10 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2003: 1 other ancestor2001: 1 other ancestor2008: 3 descendants cleared2006: 2 descendants cleared2007: 1 descendant cleared2014: 1 descendant cleared2017: 1 descendant cleared2015: 1 descendant cleared2019: 1 descendant clearedK011332 · RF-Ivd Wireless Dosimeter-Model 1133 · Sun Nuclear Corp. · 2001K021463 · Model 1133 Ivd PC Version · Sun Nuclear Corp. · 2002200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 2 descendants2 generations forward: 4 descendants3 generations forward: 1 descendant4 generations forward: 2 descendants5 generations forward: 1 descendant K021463 · Model 1133 Ivd PC Version · Sun Nuclear Corp. · 2002K011332 · RF-Ivd Wireless Dosimeter-Model 1133 · Sun Nuclear Corp. · 20010+5
  1. Root · 2 generations backK011332 RF-Ivd Wireless Dosimeter-Model 1133Sun Nuclear Corp. · 2001
  2. 1 generation backK021463 Model 1133 Ivd PC VersionSun Nuclear Corp. · 2002
  3. This deviceK040687 Onedose Patient Dosimetry SystemSicel Technologies, Inc. · 2004
  4. Descendant · cites it directly · 8 of its ownK052118 Dose Verification SystemSicel Technologies, Inc. · 2006
  5. Descendant · 2 generations on · 7 of its ownK061051 Dose Verification System Patient Dosimetry System, Models DVS-I-11…Sicel Technologies, Inc. · 2006
  6. Descendant · 2 generations on · 6 of its ownK071399 Dose Verification System Patient Dosimetry System, Model DVS-I-11…Sicel Technologies, Inc. · 2007
  7. Descendant · 2 generations on · 5 of its ownK080004 Dose Verification System Patient Dosimetry SystemSicel Technologies, Inc. · 2008
  8. Descendant · 2 generations on · 4 of its ownK083035 Dose Verification System Patient Dosimetry SystemSicel Technologies, Inc. · 2008

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2006: 22007: 12008: 32014: 12015: 12017: 12019: 1
2006high 3 (2008) · low 0 (2009)2026

Most influential descendants

Showing 5 of 10 · See all
  • K052118Dose Verification SystemSicel Technologies, Inc. · 2006 · cites it directly8descendants
  • K061051Dose Verification System Patient Dosimetry System, Models DVS-I-11, DVS Insertion Tool…Sicel Technologies, Inc. · 2006 · 2 generations on7descendants
  • K071399Dose Verification System Patient Dosimetry System, Model DVS-I-11: DVS Insertion Tool…Sicel Technologies, Inc. · 2007 · 2 generations on6descendants
  • K080004Dose Verification System Patient Dosimetry SystemSicel Technologies, Inc. · 2008 · 2 generations on5descendants
  • K083035Dose Verification System Patient Dosimetry SystemSicel Technologies, Inc. · 2008 · 2 generations on4descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K011332RF-Ivd Wireless Dosimeter-Model 1133Sun Nuclear Corp.2001—
−1K021463Model 1133 Ivd PC VersionSun Nuclear Corp.2002—
0 (this device)K040687Onedose Patient Dosimetry SystemSicel Technologies, Inc.2004—
+1K052118Dose Verification SystemSicel Technologies, Inc.2006—
+2K061051Dose Verification System Patient Dosimetry System, Models DVS-I-11, DVS…Sicel Technologies, Inc.2006—
+2K071399Dose Verification System Patient Dosimetry System, Model DVS-I-11: DVS…Sicel Technologies, Inc.2007—
+2K080004Dose Verification System Patient Dosimetry SystemSicel Technologies, Inc.2008—
+2K083035Dose Verification System Patient Dosimetry SystemSicel Technologies, Inc.2008—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200110
200310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200620
200710
200830
201410
201510
201710
201910
FIG. 1 — Lineage of K040687, 2001–2019Source: 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 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 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
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K010472Patient Dose Verification System, Model TN-RD-50
Summary page 2
…Phone: (919) 465-2236 Fax: (919) 465-0153 Predicate Device(s): / / 9 y7 Thomson Nielsen K010472 and K032725 TN-RD-50 and Autosense Wireless Dosimetry System Sun Nuclear K021463 and K011332 rf-IVD and rf-IVD PC version Devic…
Thomson & Nielsen Electronics, Ltd.2001—
*K032725Mosfet Autosense Wireless
Summary page 2
…Phone: (919) 465-2236 Fax: (919) 465-0153 Predicate Device(s): / / 9 y7 Thomson Nielsen K010472 and K032725 TN-RD-50 and Autosense Wireless Dosimetry System Sun Nuclear K021463 and K011332 rf-IVD and rf-IVD PC version Device Descriptio…
Thomson & Nielsen Electronics, Ltd.2003—
*K021463Model 1133 Ivd PC Version
Summary page 2
…(919) 465-0153 Predicate Device(s): / / 9 y7 Thomson Nielsen K010472 and K032725 TN-RD-50 and Autosense Wireless Dosimetry System Sun Nuclear K021463 and K011332 rf-IVD and rf-IVD PC version Device Description: The OneDose Patient Dosimetry System consists of the following com…
Sun Nuclear Corp.2002—
*K011332RF-Ivd Wireless Dosimeter-Model 1133
Summary page 2
…153 Predicate Device(s): / / 9 y7 Thomson Nielsen K010472 and K032725 TN-RD-50 and Autosense Wireless Dosimetry System Sun Nuclear K021463 and K011332 rf-IVD and rf-IVD PC version Device Description: The OneDose Patient Dosimetry System consists of the following components and…
Sun Nuclear Corp.2001—

Also cleared against K010472: 1 other device →

What descends from it? (10)

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

NumberDeviceApplicantDecidedDescendants
K052118Dose Verification SystemSicel Technologies, Inc.20068
K081859Modification to Onedose Patient Dosimetry SystemSicel Technologies, Inc.20080

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 3 years and passes through 2 companies; a new generation was cleared every 2.1 years on median.
  • None of the 4 ancestors has a recall.
  • Of its descendants, K052118 (Sicel Technologies, Inc., 2006) has gone furthest, with 8 descendants of its own.
  • 1 other device also cites its predicate K010472.

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 OneDose Patient Dosimetry System is intended to measure a patient's dose during radiotherapy applications.

Indications for use as stated in the FDA summary.

Also cleared against K010472

1 other device cites the same predicate.

  • K052118Dose Verification SystemSicel Technologies, Inc. · 2006

More from Sicel Technologies, Inc.

7 FDA decisions under this applicant name. See the company

  • K083035Dose Verification System Patient Dosimetry SystemSicel Technologies, Inc. · 2008
  • K081859Modification to Onedose Patient Dosimetry SystemSicel Technologies, Inc. · 2008
  • K080004Dose Verification System Patient Dosimetry SystemSicel Technologies, Inc. · 2008
  • K071399Dose Verification System Patient Dosimetry System, Model DVS-I-11: DVS Insertion Tool, DVS-D-a: DVS…Sicel Technologies, Inc. · 2007
  • K061051Dose Verification System Patient Dosimetry System, Models DVS-I-11, DVS Insertion Tool, DVS-D-a, DVS DosimeterSicel Technologies, Inc. · 2006

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/K040687 · printed Nov 6, 2026

Cite this page

510(k) Report. “K040687: Onedose Patient Dosimetry System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040687

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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