510(k) · Cleared
ClearedHead and Neck Immobilization System, Body Immobilization System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtec, Inc. · LNH System, Nuclear Magnetic Resonance Imaging
Cleared on Jun 28, 2011 as substantially equivalent to K080072 (CIVCO Medical Instruments Co., Inc., 2008) and 2 other predicates after a 47-day review. Its family tree reaches back 4 generations to 1991. 13 later devices descend from it.
- Decided
- Jun 28, 2011
- Review
- 47 days
- Class
- Class II
- Product code
- LNH
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 4 generations to K905007 (1991). 16 ancestors in all. 13 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK905007 Standard Breast Boards; Deluxe Breast BoardBionix Development Corp. · 1991
- 3 generations backK030051 Versaboard, Model 7040Bionix Development Corp. · 2003
- 2 generations backK060737 Sinmed Positioning DevicesSinmed BV · 2006
- 1 generation backK093738 Mri Patient Positioning DevicesMedtec, Inc. · 2010
- This deviceK111340 Head and Neck Immobilization System, Body Immobilization SystemMedtec, Inc. · 2011
- Descendant · cites it directly · 7 of its ownK142420 Patient Positioning DevicesMacromedics BV · 2015
- Descendant · cites it directly · 5 of its ownK122888 CDR Systems Precision Patient Positioning SystemCdr Systems, Inc. · 2013
- Descendant · 2 generations on · 3 of its ownK153026 Body Pro-Lok Respiratory Plate, Respiratory Plate Cushion, Body…Medtec, Inc. D/B/A Civco Medical Solutions · 2016
- Descendant · 2 generations on · 2 of its ownK212909 VacuumCushions, FeetSupports, LEPS (Lower Extermities Positioning…Macromedics BV · 2022
- Descendant · 2 generations on · 1 of its ownK222977 DSPS-Prominent™ Masks; DSPS-Prominent™ Baseplate, MR; CouchStripMacromedics BV · 2023
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K142420Patient Positioning DevicesMacromedics BV · 2015 · cites it directly7descendants
- K122888CDR Systems Precision Patient Positioning SystemCdr Systems, Inc. · 2013 · cites it directly5descendants
- K153026Body Pro-Lok Respiratory Plate, Respiratory Plate Cushion, Body Pro-Respiratory Belt…Medtec, Inc. D/B/A Civco Medical Solutions · 2016 · 2 generations on3descendants
- K212909VacuumCushions, FeetSupports, LEPS (Lower Extermities Positioning System), CouchStripsMacromedics BV · 2022 · 2 generations on2descendants
- K222977DSPS-Prominent™ Masks; DSPS-Prominent™ Baseplate, MR; CouchStripMacromedics BV · 2023 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K905007 | Standard Breast Boards; Deluxe Breast Board | Bionix Development Corp. | 1991 | — |
| −3 | K030051 | Versaboard, Model 7040 | Bionix Development Corp. | 2003 | — |
| −2 | K060737 | Sinmed Positioning Devices | Sinmed BV | 2006 | — |
| −1 | K093738 | Mri Patient Positioning Devices | Medtec, Inc. | 2010 | — |
| 0 (this device) | K111340 | Head and Neck Immobilization System, Body Immobilization System | Medtec, Inc. | 2011 | — |
| +1 | K142420 | Patient Positioning Devices | Macromedics BV | 2015 | — |
| +1 | K122888 | CDR Systems Precision Patient Positioning System | Cdr Systems, Inc. | 2013 | — |
| +2 | K153026 | Body Pro-Lok Respiratory Plate, Respiratory Plate Cushion, Body… | Medtec, Inc. D/B/A Civco Medical Solutions | 2016 | — |
| +2 | K212909 | VacuumCushions, FeetSupports, LEPS (Lower Extermities Positioning System)… | Macromedics BV | 2022 | — |
| +2 | K222977 | DSPS-Prominent™ Masks; DSPS-Prominent™ Baseplate, MR; CouchStrip | Macromedics BV | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 2002 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2025 | 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 LNH? 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 LNH device
- #1 K213693 MAGNETOM Vida with syngo MR XA50Ascore 23.0 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K972842 | FDA’s K972842 is Interpore Inducer Bone Graft Delivery Syringe Our reading of the summary gave K972842, FDA’s number for Interpore Inducer Bone Graft Delivery Syringe (Interpore Intl.). Its FDA name has none of the distinctive words the summary uses for the device it names, “CIVCO Patient Positioning Devices”. Kept off the family tree. Summary page 2…., doing business as CJYCO Medical Solutions, claim the proposed devices to be substantially equivalent to the devices previously cleared by FDA in the following Sl0k's: K972842, K080072, K093738, K935000 and K(954225. MEDTEC, Inc., doing business as CIVCO Medical Solutions, claim this equivalence because… | 1997 |
| * | K080072 | Mri Patient Positioning DevicesSummary page 2…business as CJYCO Medical Solutions, claim the proposed devices to be substantially equivalent to the devices previously cleared by FDA in the following Sl0k's: K972842, K080072, K093738, K935000 and K(954225. MEDTEC, Inc., doing business as CIVCO Medical Solutions, claim this equivalence because the propo… | 2008 |
| * | K093738 | Mri Patient Positioning DevicesSummary page 2…as CJYCO Medical Solutions, claim the proposed devices to be substantially equivalent to the devices previously cleared by FDA in the following Sl0k's: K972842, K080072, K093738, K935000 and K(954225. MEDTEC, Inc., doing business as CIVCO Medical Solutions, claim this equivalence because the proposed devic… | 2010 |
| Kept off the family tree | K935000 | CIVCO Patient Positioning Devices Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 2…Medical Solutions, claim the proposed devices to be substantially equivalent to the devices previously cleared by FDA in the following Sl0k's: K972842, K080072, K093738, K935000 and K(954225. MEDTEC, Inc., doing business as CIVCO Medical Solutions, claim this equivalence because the proposed devices have e… | |
| * | K954225 | Med-Tec Hand GripSummary page 2…ons, claim the proposed devices to be substantially equivalent to the devices previously cleared by FDA in the following Sl0k's: K972842, K080072, K093738, K935000 and K(954225. MEDTEC, Inc., doing business as CIVCO Medical Solutions, claim this equivalence because the proposed devices have equivalent int… | 1995 |
What descends from it? (13)
See all 133 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 20 years and passes through 3 companies; a new generation was cleared every 4.1 years on median.
- 2 of the 16 ancestors have a recall of any class.
- Of its descendants, K142420 (Macromedics BV, 2015) has gone furthest, with 7 descendants of its own.
- 2 other devices also cite its predicate K080072.
How does its category compare?
All LNH devicesLNH System, Nuclear Magnetic Resonance Imaging: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · LNH
26in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LNH
122in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LNH
8in 2025
Class I (8 since 2007) Class II/III not classified
Adverse event reports per year · LNH
1,263in 2025
MAUDE reports naming product code LNH, 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 | 12 | 35 | 25 | 114 |
| 2008 | 19 | 53 | 12 | 167 |
| 2009 | 17 | 70 | 7 | 194 |
| 2010 | 12 | 94 | 17 | 165 |
| 2011 | 16 | 81 | 11 | 182 |
| 2012 | 22 | 89 | 5 | 170 |
| 2013 | 19 | 108 | 2 | 107 |
| 2014 | 17 | 108 | 13 | 119 |
| 2015 | 19 | 140 | 12 (2) | 113 |
| 2016 | 20 | 108 | 1 | 135 |
| 2017 | 18 | 98 | 0 | 121 |
| 2018 | 29 | 128 | 71 | 158 |
| 2019 | 26 | 62 | 5 | 158 |
| 2020 | 32 | 121 | 4 | 98 |
| 2021 | 27 | 87 | 41 | 84 |
| 2022 | 30 | 74 | 13 | 138 |
| 2023 | 30 | 124 | 10 (1) | 159 |
| 2024 | 26 | 104 | 4 | 281 |
| 2025 | 26 | 122 | 8 (5) | 1,263 |
| 2026 | 24 | 126 | 43 | — |
What is it indicated for?
CIVCO Patient Positioning Devices are used to aid in the support and positioning of patients during MR, radiological, and other procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111340 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111340: Head and Neck Immobilization System, Body Immobilization System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111340
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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