510(k) · Cleared

Recalled · Class II · 2020

Uni-Frame Head Immobilization System

K933227510(k) TraditionalCleared Jul 18, 1994381-day reviewClass II21 CFR 892.5050Recalls 2

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Medtec, Inc. · IYE Accelerator, Linear, Medical

Cleared on Jul 18, 1994 after a 381-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 22 later devices descend from it. It has been recalled 2 times.

Decided: Jul 18, 1994
Review: 381 days
Class: Class II
Product code: IYE
Recalls: 2
Predicates: 0

22 later devices descend from it, 4 citing it directly.

This deviceK933227 Uni-Frame Head Immobilization SystemMedtec, Inc. · 1994
Descendant · cites it directly · 18 of its ownK030051 Versaboard, Model 7040Bionix Development Corp. · 2003
Descendant · 2 generations on · 17 of its ownK060737 Sinmed Positioning DevicesSinmed BV · 2006
Descendant · cites it directly · 15 of its ownK080072 Mri Patient Positioning DevicesCIVCO Medical Instruments Co., Inc. · 2008
Descendant · 2 generations on · 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

Showing 5 of 22 descendants. See all descendants

Descendants cleared per year

1998high 2 (2010) · low 0 (1999)2026

Most influential descendants

Showing 5 of 22 · See all

K030051Versaboard, Model 7040Bionix Development Corp. · 2003 · cites it directly18descendants
K060737Sinmed Positioning DevicesSinmed BV · 2006 · 2 generations on17descendants
K080072Mri Patient Positioning DevicesCIVCO Medical Instruments Co., Inc. · 2008 · cites it directly15descendants
K093738Mri Patient Positioning DevicesMedtec, Inc. · 2010 · 2 generations on14descendants
K111340Head and Neck Immobilization System, Body Immobilization SystemMedtec, Inc. · 2011 · 2 generations on13descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K933227	Uni-Frame Head Immobilization System	Medtec, Inc.	1994	—
+1	K030051	Versaboard, Model 7040	Bionix Development Corp.	2003	—
+2	K060737	Sinmed Positioning Devices	Sinmed BV	2006	—
+1	K080072	Mri Patient Positioning Devices	CIVCO Medical Instruments Co., Inc.	2008	—
+2	K093738	Mri Patient Positioning Devices	Medtec, Inc.	2010	—
+2	K111340	Head and Neck Immobilization System, Body Immobilization System	Medtec, Inc.	2011	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
2003	1	0
2005	1	0
2006	1	0
2008	1	0
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 K933227, 1994–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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

Get a 510(k) Report

What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (22)

See all 22

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

Number	Device	Applicant	Decided	Descendants
K030051	Versaboard, Model 7040	Bionix Development Corp.	2003	18
K080072	Mri Patient Positioning Devices	CIVCO Medical Instruments Co., Inc.	2008	15
K050701	Thigh and Foot Positioner, Suprone Plus, Model RT-6010	Bionix Development Corp.	2005	6
K981115	Radio-Plast	Smith & Nephew, Inc.	1998	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
May 12, 2020	Class II	Z-2243-2020	Component design/selection	Potential for disengagement of the Varian Style Type-S Extension during patient repositioning. The risk associated with the disengagement of the extension could be a patient fall if the patient is not supported by clinical staff.
Aug 31, 2009	Not classified	Z-0124-2010	Process control	Some of the packages contain the incorrect mask style.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K030051 (Bionix Development Corp., 2003) has gone furthest, with 18 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	—

https://510kreport.com/device/K933227 · printed Nov 6, 2026

Cite this page

510(k) Report. “K933227: Uni-Frame Head 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/K933227

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026