510(k) · Cleared

Cleared

Sinmed Positioning Devices

K060737510(k) TraditionalCleared Mar 31, 200611-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

Sinmed BV · IYE Accelerator, Linear, Medical

Cleared on Mar 31, 2006 as substantially equivalent to K933613 (Bionix Development Corp., 1993) and 6 other predicates after an 11-day review. Its family tree reaches back 2 generations to 1991. 17 later devices descend from it.

Decided: Mar 31, 2006
Review: 11 days
Class: Class II
Product code: IYE
Recalls: None
Predicates: 7

Its longest line of descent runs back 2 generations to K905007 (1991). 9 ancestors in all. 17 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 2 generations backK905007 Standard Breast Boards; Deluxe Breast BoardBionix Development Corp. · 1991
1 generation backK030051 Versaboard, Model 7040Bionix Development Corp. · 2003
This deviceK060737 Sinmed Positioning DevicesSinmed BV · 2006
Descendant · cites it directly · 14 of its ownK093738 Mri Patient Positioning DevicesMedtec, Inc. · 2010
Descendant · 2 generations on · 13 of its ownK111340 Head and Neck Immobilization System, Body Immobilization SystemMedtec, Inc. · 2011
Descendant · cites it directly · 7 of its ownK142420 Patient Positioning DevicesMacromedics BV · 2015
Descendant · 3 generations on · 5 of its ownK122888 CDR Systems Precision Patient Positioning SystemCdr Systems, Inc. · 2013
Descendant · 4 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 17 descendants. See all descendants

Descendants cleared per year

2010high 2 (2010) · low 0 (2014)2026

Most influential descendants

Showing 5 of 17 · See all

K093738Mri Patient Positioning DevicesMedtec, Inc. · 2010 · cites it directly14descendants
K111340Head and Neck Immobilization System, Body Immobilization SystemMedtec, Inc. · 2011 · 2 generations on13descendants
K142420Patient Positioning DevicesMacromedics BV · 2015 · cites it directly7descendants
K122888CDR Systems Precision Patient Positioning SystemCdr Systems, Inc. · 2013 · 3 generations on5descendants
K153026Body Pro-Lok Respiratory Plate, Respiratory Plate Cushion, Body Pro-Respiratory Belt…Medtec, Inc. D/B/A Civco Medical Solutions · 2016 · 4 generations on3descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K905007	Standard Breast Boards; Deluxe Breast Board	Bionix Development Corp.	1991	—
−1	K030051	Versaboard, Model 7040	Bionix Development Corp.	2003	—
0 (this device)	K060737	Sinmed Positioning Devices	Sinmed BV	2006	—
+1	K093738	Mri Patient Positioning Devices	Medtec, Inc.	2010	—
+2	K111340	Head and Neck Immobilization System, Body Immobilization System	Medtec, Inc.	2011	—
+1	K142420	Patient Positioning Devices	Macromedics BV	2015	—
+3	K122888	CDR Systems Precision Patient Positioning System	Cdr Systems, Inc.	2013	—
+4	K153026	Body Pro-Lok Respiratory Plate, Respiratory Plate Cushion, Body…	Medtec, Inc. D/B/A Civco Medical Solutions	2016	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1993	1	0
1994	3	0
1995	1	0
1998	1	0
2002	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2010	2	0
2011	1	0
2012	1	0
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

FIG. 1 — Lineage of K060737, 1991–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 K252977 Halcyon, Ethos Radiotherapy System (5.0)score 18.8 · 18 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (7)

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	Applicant	Decided	Recalls
*	K933613	3-Way Head Immobilizer; 3WAY Deluxe Reusable Frame Head Immobilizer Summary page 1 …DeLuxe Reusable Frame, manufactured by Bionix Development corporation. Registration number: 1526854) and cleared by FDA with K933613 Description of the devices: See Sinmed Page: Product: product Catalogue 2006 4 -Posifix 1,…	Bionix Development Corp.	1993	—
*	K030051	Versaboard, Model 7040 Summary page 3 …manufactured by Bionix Development Corporation, Registration number: 1526854) and cleared by FDA with K030051 Description of the devices: See Sinmed Page: Product: product Catalogue 2006 8 Posifix-E…	Bionix Development Corp.	2003	—
*	K974703	Carbon Fiber Breast Board Summary page 5 …BOARD, manufactured by MED-TEC.INC. (Registration number: 1932738) and cleared by FDA with K974703. Description of the devices: See Sinmed Page: Product: product Catalogue 2006 27 Thoraw…	Medtec, Inc.	1998	—
*	K023293	Med-Tec Bellyboard, Models MT-Bba-01 & MT-Bba-02 Summary page 7 …Bellyboard, manufactured by MedTec. INC. (Registration number: 1932738) and cleared by FDA with K023293. Description of the devices: See Sinmed Page: Product: product Catalogue 2006 31 Bellyboa…	Med-Tec,Inc.	2002	—
*	K950866	Hip Fixation System Summary page 9 …System manufactured by MedTec. INC. (Registration number: 1932738) and cleared by FDA with K950866. Description of the devices: See Sinmed Page: Product: product Catalogue 2006 36 Posifix…	Medtec, Inc.	1995	—
*	K935300	Vac-Lok Immobilization System Summary page 11 …manufactured by Med-Tec INC. (Registration number: 1932738) and cleared by FDA with K(935300. Description of the devices: See Sinnmed Page: Product: product Catalogue 2006 45 R…	Medtec, Inc.	1994	—
*	K926187	Posicast Immobilization System Summary page 13 …registered by Huestis Machine Corporation. (Registration number: 1219183) and cleared by FDA with K9261 87. The following table compares the Sinred POSICAST IMMOBILIZATION SYSTEM and the predicate dev…	Huestis Machine Corp.	1994	—

What descends from it? (17)

See all 17

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

Number	Device	Applicant	Decided	Descendants
K093738	Mri Patient Positioning Devices	Medtec, Inc.	2010	14
K142420	Patient Positioning Devices	Macromedics BV	2015	7
K121545	Bellyboard, SBRT Accessories	Medtec Inc. Dba Civco Medical Solutions	2012	0
K100264	T-Form Extremity Immobilizer, Model RT-6060	Bionix Development Corp.	2010	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 15 years and passes through 2 companies; a new generation was cleared every 12.1 years on median.
1 of the 9 ancestors has a recall of any class.
Of its descendants, K093738 (Medtec, Inc., 2010) has gone furthest, with 14 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

2007high 28 (2012) · low 9 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IYE

170in 2025

2007high 239 (2024) · low 44 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · IYE

1in 2025

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	23	44	78	155
2008	14	69	49	114
2009	20	63	22	174
2010	23	74	27	246
2011	11	94	73	280
2012	28	106	20	128
2013	18	88	11	96
2014	20	100	14	124
2015	20	108	8	100
2016	21	97	7	97
2017	23	94	7	125
2018	21	58	7	85
2019	19	83	2	91
2020	20	67	4	74
2021	19	86	5	68
2022	12	172	3	66
2023	18	129	7	128
2024	9	239	1	81
2025	12	170	1	101
2026	14	120	4	—

What is it indicated for?

Fixation and (re)positioning of the head- and neck area of the patient during radiotherapy and diagnostics.

Fixation and (re~positioning of the head- and neck area of the patient during radiotherapy and diagnostics.

Positioning of the lung- and thorax area of the patient during radiotherapy and diagnostics.

Positioning of the lower abdomen of a patient during radiotherapy and diagnostics.

Positioning of hip and lower extremities of a patient during radiotherapy and diagnostics.

Fixation and (re~positioning of the patient during radiotherapy and diagnostics,

Fixation and (re)positioning of the patient during radiotherapy and diagnostics.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K060737 · printed Nov 4, 2026

Cite this page

510(k) Report. “K060737: Sinmed 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/K060737

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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