510(k) Report

510(k) · Cleared

Cleared

Med-Tec Bellyboard, Models MT-Bba-01 & MT-Bba-02

K023293510(k) TraditionalCleared Dec 23, 200282-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

Med-Tec,Inc. · IYE Accelerator, Linear, Medical

Cleared on Dec 23, 2002 after an 82-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 22 later devices descend from it.

Decided
Dec 23, 2002
Review
82 days
Class
Class II
Product code
IYE
Recalls
None
Predicates
0

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

Descendants, by year cleared 2006: 1 descendant cleared2004: 1 descendant cleared2016: 3 descendants cleared2013: 3 descendants cleared2015: 1 descendant cleared2012: 1 descendant cleared2010: 2 descendants cleared2011: 1 descendant cleared2018: 1 descendant cleared2022: 2 descendants cleared2023: 2 descendants cleared2021: 1 descendant cleared2020: 1 descendant cleared2017: 1 descendant cleared2025: 1 descendant cleared200020052010201520202025
  1. This deviceK023293 Med-Tec Bellyboard, Models MT-Bba-01 & MT-Bba-02Med-Tec,Inc. · 2002
  2. Descendant · cites it directly · 17 of its ownK060737 Sinmed Positioning DevicesSinmed BV · 2006
  3. Descendant · 2 generations on · 14 of its ownK093738 Mri Patient Positioning DevicesMedtec, Inc. · 2010
  4. Descendant · 3 generations on · 13 of its ownK111340 Head and Neck Immobilization System, Body Immobilization SystemMedtec, Inc. · 2011
  5. Descendant · cites it directly · 9 of its ownK040773 Pelvis Bellyboard Plus Patient Positioning SystemBionix Development Corp. · 2004
  6. Descendant · 2 generations on · 7 of its ownK142420 Patient Positioning DevicesMacromedics BV · 2015

Showing 5 of 22 descendants. See all descendants

Descendants cleared per year

2004: 12006: 12010: 22011: 12012: 12013: 32015: 12016: 32017: 12018: 12020: 12021: 12022: 22023: 22025: 1
2004high 3 (2013) · low 0 (2005)2026

Most influential descendants

Showing 5 of 22 · See all
  • K060737Sinmed Positioning DevicesSinmed BV · 2006 · cites it directly17descendants
  • K093738Mri Patient Positioning DevicesMedtec, Inc. · 2010 · 2 generations on14descendants
  • K111340Head and Neck Immobilization System, Body Immobilization SystemMedtec, Inc. · 2011 · 3 generations on13descendants
  • K040773Pelvis Bellyboard Plus Patient Positioning SystemBionix Development Corp. · 2004 · cites it directly9descendants
  • K142420Patient Positioning DevicesMacromedics BV · 2015 · 2 generations on7descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K023293Med-Tec Bellyboard, Models MT-Bba-01 & MT-Bba-02Med-Tec,Inc.2002—
+1K060737Sinmed Positioning DevicesSinmed BV2006—
+2K093738Mri Patient Positioning DevicesMedtec, Inc.2010—
+3K111340Head and Neck Immobilization System, Body Immobilization SystemMedtec, Inc.2011—
+1K040773Pelvis Bellyboard Plus Patient Positioning SystemBionix Development Corp.2004—
+2K142420Patient Positioning DevicesMacromedics BV2015—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200610
201020
201110
201210
201330
201510
201630
201710
201810
202010
202110
202220
202320
202510
FIG. 1 — Lineage of K023293, 2002–2025Source: 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
Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (22)

See all 22

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

NumberDeviceApplicantDecidedDescendants
K060737Sinmed Positioning DevicesSinmed BV200617
K040773Pelvis Bellyboard Plus Patient Positioning SystemBionix Development Corp.20049

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, K060737 (Sinmed BV, 2006) has gone furthest, with 17 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 intended use of this device is to provide a cutout for displacement of the small bowel from the treatment area.

The belly board can be used by it's self or with MED-TEC's HipFix system.

The MED-TEC bellyboard is placed on the treatment table and has a cutout that aids in the displacement of the small bowel from the treatment area.

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

More from Med-Tec,Inc.

8 FDA decisions under this applicant name. See the company

  • K034054Pro Series Couch Software, Model MT-PRO100Med-Tec,Inc. · 2004
  • K031866Med-Tec 6 Degree Axis Couch, Model MT-6DACMed-Tec,Inc. · 2003
  • K021360Scintillating Fiber Dosimeter (SFD), Model MT-SFD-1000Med-Tec,Inc. · 2003
  • K013875Med-Tec Compensator Block Cutter SoftwareMed-Tec,Inc. · 2002
  • K001052Med-Tec (Medical Intelligence) Bodyfix System, Model MT-BFXMed-Tec,Inc. · 2000

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/K023293 · printed Nov 6, 2026

Cite this page

510(k) Report. “K023293: Med-Tec Bellyboard, Models MT-Bba-01 & MT-Bba-02.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023293

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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