510(k) Report

510(k) · Cleared

Cleared

Mri Patient Positioning Devices

K080072510(k) TraditionalCleared Jun 4, 2008145-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

CIVCO Medical Instruments Co., Inc. · IYE Accelerator, Linear, Medical

Cleared on Jun 4, 2008 as substantially equivalent to K973842 (Medtec, Inc., 1997) and 4 other predicates after a 145-day review. Its family tree reaches back 1 generation to 1994. 15 later devices descend from it.

Decided
Jun 4, 2008
Review
145 days
Class
Class II
Product code
IYE
Recalls
None
Predicates
5

Its longest line of descent runs back 1 generation to K933227 (1994). 5 ancestors in all. 15 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1998: 1 other ancestor1997: 1 other ancestor1995: 1 other ancestor1994: 1 other ancestor2015: 1 descendant cleared2011: 1 descendant cleared2010: 1 descendant cleared2013: 2 descendants cleared2022: 2 descendants cleared2023: 2 descendants cleared2021: 1 descendant cleared2020: 1 descendant cleared2018: 1 descendant cleared2016: 1 descendant cleared2025: 1 descendant cleared2017: 1 descendant clearedK933227 · Uni-Frame Head Immobilization System · Medtec, Inc. · 1994 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors 1 generation forward: 3 descendants2 generations forward: 7 descendants3 generations forward: 4 descendants4 generations forward: 1 descendant K933227 · Uni-Frame Head Immobilization System · Medtec, Inc. · 1994 · recalled0
  1. Root · 1 generation backK933227 Uni-Frame Head Immobilization SystemMedtec, Inc. · 1994 · Recalled
  2. This deviceK080072 Mri Patient Positioning DevicesCIVCO Medical Instruments Co., Inc. · 2008
  3. Descendant · cites it directly · 14 of its ownK093738 Mri Patient Positioning DevicesMedtec, Inc. · 2010
  4. Descendant · cites it directly · 13 of its ownK111340 Head and Neck Immobilization System, Body Immobilization SystemMedtec, Inc. · 2011
  5. Descendant · cites it directly · 7 of its ownK142420 Patient Positioning DevicesMacromedics BV · 2015
  6. Descendant · 2 generations on · 5 of its ownK122888 CDR Systems Precision Patient Positioning SystemCdr Systems, Inc. · 2013
  7. 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

Showing 5 of 15 descendants. See all descendants

Descendants cleared per year

2010: 12011: 12013: 22015: 12016: 12017: 12018: 12020: 12021: 12022: 22023: 22025: 1
2010high 2 (2013) · low 0 (2012)2026

Most influential descendants

Showing 5 of 15 · See all
  • K093738Mri Patient Positioning DevicesMedtec, Inc. · 2010 · cites it directly14descendants
  • K111340Head and Neck Immobilization System, Body Immobilization SystemMedtec, Inc. · 2011 · cites it directly13descendants
  • K142420Patient Positioning DevicesMacromedics BV · 2015 · cites it directly7descendants
  • 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
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K933227Uni-Frame Head Immobilization SystemMedtec, Inc.19942
0 (this device)K080072Mri Patient Positioning DevicesCIVCO Medical Instruments Co., Inc.2008—
+1K093738Mri Patient Positioning DevicesMedtec, Inc.2010—
+1K111340Head and Neck Immobilization System, Body Immobilization SystemMedtec, Inc.2011—
+1K142420Patient Positioning DevicesMacromedics BV2015—
+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—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199410
199510
199710
199810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
201110
201320
201510
201610
201710
201810
202010
202110
202220
202320
202510
FIG. 1 — Lineage of K080072, 1994–2025Source: 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 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? (5)

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
*K973842Carbon Fiber Conformal Couch Top
Summary page 1
…re the classification was reduced to Class I exempt. This 510(k) is to have these identical Class I products cleared for use in an MIRI environment. Predicate Devices: K973842 - Medtec Inc, Carbon Fiber Conformal Couch Top K951808 - Medtec Inc, Med-Tec Redi-Foam K982624 - Medtec Inc, Moldcare Head & Neck…
Medtec, Inc.19977
*K951808Med-Tec Redi-Foam
Summary page 1
…is 510(k) is to have these identical Class I products cleared for use in an MIRI environment. Predicate Devices: K973842 - Medtec Inc, Carbon Fiber Conformal Couch Top K951808 - Medtec Inc, Med-Tec Redi-Foam K982624 - Medtec Inc, Moldcare Head & Neck Cushion K933227 - Medtec Inc, Uni-Frame Head Immobiliz…
Medtec, Inc.1995—
*K982624Moldcare Head & Neck Cushion, Model # MT-Acl-14242
Summary page 1
…ss I products cleared for use in an MIRI environment. Predicate Devices: K973842 - Medtec Inc, Carbon Fiber Conformal Couch Top K951808 - Medtec Inc, Med-Tec Redi-Foam K982624 - Medtec Inc, Moldcare Head & Neck Cushion K933227 - Medtec Inc, Uni-Frame Head Immobilization System K935300 - Medtec Inc, Vac-L…
Med-Tec,Inc.1998—
*K933227Uni-Frame Head Immobilization System
Summary page 1
…t. Predicate Devices: K973842 - Medtec Inc, Carbon Fiber Conformal Couch Top K951808 - Medtec Inc, Med-Tec Redi-Foam K982624 - Medtec Inc, Moldcare Head & Neck Cushion K933227 - Medtec Inc, Uni-Frame Head Immobilization System K935300 - Medtec Inc, Vac-Lok Immobilizatioin System…
Medtec, Inc.19942
*K935300Vac-Lok Immobilization System
Summary page 1
…Conformal Couch Top K951808 - Medtec Inc, Med-Tec Redi-Foam K982624 - Medtec Inc, Moldcare Head & Neck Cushion K933227 - Medtec Inc, Uni-Frame Head Immobilization System K935300 - Medtec Inc, Vac-Lok Immobilizatioin System…
Medtec, Inc.1994—

Also cleared against K973842: 4 other devices →

What descends from it? (15)

See all 15

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

NumberDeviceApplicantDecidedDescendants
K093738Mri Patient Positioning DevicesMedtec, Inc.201014
K111340Head and Neck Immobilization System, Body Immobilization SystemMedtec, Inc.201113
K142420Patient Positioning DevicesMacromedics BV20157

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?

  • 2 of the 5 ancestors have a recall of any class.
  • Of its descendants, K093738 (Medtec, Inc., 2010) has gone furthest, with 14 descendants of its own.
  • 4 other devices also cite its predicate K973842.

How does its category compare?

All IYE devices

IYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

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?

Patient Positioning Devices are used to aid in the support and positioning of patients during an MRI.

Indications for use as stated in the FDA summary.

Also cleared against K973842

4 other devices cite the same predicate.

  • K180021Proton Positioing and Immobilization DevicesMedtec Inc Dba Civco Medical Solutions and Civco Radiotherap · 2018
  • K121545Bellyboard, SBRT AccessoriesMedtec Inc. Dba Civco Medical Solutions · 20122 recalls
  • K093738Mri Patient Positioning DevicesMedtec, Inc. · 2010
  • K040773Pelvis Bellyboard Plus Patient Positioning SystemBionix Development Corp. · 2004

More from CIVCO Medical Instruments Co., Inc.

30 FDA decisions under this applicant name. See the company

  • K260114Align® Cover and Pad Guidance ToolCIVCO Medical Instruments Co., Inc. · 2026
  • K231783VitroPROCIVCO Medical Instruments Co., Inc. · 2023
  • K222052VitroPROCIVCO Medical Instruments Co., Inc. · 2022
  • K211270CIV-Clear coverCIVCO Medical Instruments Co., Inc. · 2021
  • K163313ASTRA TEE Transesophageal Probe Reprocessor, ASTRA VR Endovaginal/Endorectal Probe ReprocessorCIVCO Medical Instruments Co., Inc. · 2017

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/K080072 · printed Nov 4, 2026

Cite this page

510(k) Report. “K080072: Mri Patient Positioning Devices.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K080072

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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