510(k) · Cleared
ClearedTrueFit Bolus; TrueFlex Bolus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Adaptiiv Medical Technologies, Inc. · MUJ System, Planning, Radiation Therapy Treatment
Cleared on Oct 23, 2024 as substantially equivalent to K213438 (Adaptiiv, 2022) after a 26-day review. Its family tree reaches back 7 generations to 1997. 1 later device descends from it.
- Decided
- Oct 23, 2024
- Review
- 26 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K971367 (1997). 8 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK971367 Brainscan Conformal RT ModuleBrainlab AG · 1997
- 6 generations backK032762 Xio Radiation Treatment Planning SystemComputerized Medical Systems, Inc. · 2003
- 5 generations backK061440 P.D.Decimal, Inc. · 2006
- 4 generations backK083672 P.D Software.Decimal, Inc. · 2009
- 3 generations backK151369 .decimal p.d.Decimal, LLC · 2015
- 2 generations backK180289 3D Bolus Software3D Bolus, Inc. · 2018
- 1 generation backK213438 3D Bolus Software Application, 3D Brachy Software Application…Adaptiiv · 2022
- This deviceK243057 TrueFit Bolus; TrueFlex BolusAdaptiiv Medical Technologies, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK260308 TrueFit BolusAdaptiiv Medical Technologies, Inc. · 2026
Most influential descendants
Showing 1 of 1 · See all- K260308TrueFit BolusAdaptiiv Medical Technologies, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K971367 | Brainscan Conformal RT Module | Brainlab AG | 1997 | — |
| −6 | K032762 | Xio Radiation Treatment Planning System | Computerized Medical Systems, Inc. | 2003 | — |
| −5 | K061440 | P.D | .Decimal, Inc. | 2006 | — |
| −4 | K083672 | P.D Software | .Decimal, Inc. | 2009 | — |
| −3 | K151369 | .decimal p.d | .Decimal, LLC | 2015 | — |
| −2 | K180289 | 3D Bolus Software | 3D Bolus, Inc. | 2018 | — |
| −1 | K213438 | 3D Bolus Software Application, 3D Brachy Software Application, Patient-Matched… | Adaptiiv | 2022 | — |
| 0 (this device) | K243057 | TrueFit Bolus; TrueFlex Bolus | Adaptiiv Medical Technologies, Inc. | 2024 | — |
| +1 | K260308 | TrueFit Bolus | Adaptiiv Medical Technologies, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 1 | 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 MUJ? 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 MUJ device
- #1 K232799 syngo.via RT Image Suitescore 18.6 · 19 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K213438 | 3D Bolus Software Application, 3D Brachy Software Application, Patient-Matched 3D…Summary page 5…apy Treatment Regulation Number 892.5050 Product Code MUJ Legally Marketed Predicate Devices Predicate # K213438 Predicate Trade Name Patient-Matched 3D Printed Radiation Therapy Accessory Product Code MU… | 2022 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K260308 | TrueFit Bolus | 2026 | 0 |
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 27 years and passes through 7 companies; a new generation was cleared every 2.9 years on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K260308 (Adaptiiv Medical Technologies, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K213438.
How does its category compare?
All MUJ devicesMUJ System, Planning, Radiation Therapy Treatment: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · MUJ
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MUJ
186in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MUJ
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MUJ
21in 2025
MAUDE reports naming product code MUJ, 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 | 4 | 67 | 4 | 24 |
| 2008 | 9 | 63 | 10 | 51 |
| 2009 | 16 | 84 | 11 | 24 |
| 2010 | 11 | 56 | 23 | 78 |
| 2011 | 9 | 103 | 17 | 73 |
| 2012 | 8 | 59 | 4 | 39 |
| 2013 | 5 | 64 | 6 | 33 |
| 2014 | 9 | 108 | 2 | 35 |
| 2015 | 13 | 78 | 7 | 30 |
| 2016 | 5 | 80 | 13 | 27 |
| 2017 | 7 | 30 | 4 | 16 |
| 2018 | 7 | 53 | 3 | 25 |
| 2019 | 9 | 56 | 4 | 25 |
| 2020 | 9 | 104 | 2 | 26 |
| 2021 | 11 | 87 | 4 | 15 |
| 2022 | 8 | 168 | 3 | 22 |
| 2023 | 10 | 140 | 2 | 76 |
| 2024 | 9 | 122 | 0 | 9 |
| 2025 | 10 | 186 | 0 | 21 |
| 2026 | 9 | 233 | 2 | — |
What is it indicated for?
TrueFit/TrueFlex Bolus is indicated for and intended to be placed on the patient’s skin as an accessory to attenuate and/or compensate the external beam (photon or electron) radiation during the treatment of various types of cancer.
The device is for a single patient’s use only and can be reused throughout the entirety of the treatment course.
The device is designed by the radiation therapy professional using patient imaging data as input and must be verified and approved by the trained radiation therapy professional prior to use.
The device is restricted to sale by or on the order of a physician and is by prescription only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243057 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243057: TrueFit Bolus; TrueFlex Bolus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243057
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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