510(k) · Cleared

Cleared

Moldcare Head & Neck Cushion, Model # MT-Acl-14242

K982624510(k) TraditionalCleared Oct 26, 199890-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 Oct 26, 1998 after a 90-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 19 later devices descend from it.

Decided: Oct 26, 1998
Review: 90 days
Class: Class II
Product code: IYE
Recalls: None
Predicates: 0

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

This deviceK982624 Moldcare Head & Neck Cushion, Model # MT-Acl-14242Med-Tec,Inc. · 1998
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
Descendant · 2 generations on · 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

Showing 5 of 19 descendants. See all descendants

Descendants cleared per year

2008high 3 (2013) · low 0 (2009)2026

Most influential descendants

Showing 5 of 19 · See all

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
K142420Patient Positioning DevicesMacromedics BV · 2015 · 2 generations on7descendants
K122888CDR Systems Precision Patient Positioning SystemCdr Systems, Inc. · 2013 · 3 generations on5descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K982624	Moldcare Head & Neck Cushion, Model # MT-Acl-14242	Med-Tec,Inc.	1998	—
+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	—
+2	K142420	Patient Positioning Devices	Macromedics BV	2015	—
+3	K122888	CDR Systems Precision Patient Positioning System	Cdr Systems, Inc.	2013	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0
2010	1	0
2011	1	0
2013	3	0
2015	1	0
2016	3	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 K982624, 1998–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

What descends from it? (19)

See all 19

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

Number	Device	Applicant	Decided	Descendants
K080072	Mri Patient Positioning Devices	CIVCO Medical Instruments Co., Inc.	2008	15
K132124	Klarity Vacuum Bag, Klarity Mold Cushion	Klarity Medical Products, LLC	2013	1
K162002	Z-Box/Z-Tilt Breast and Thoracic Positioning Device, Z-Square Indexing System, Z-Foam…	Zdi, Solutions, LLC	2016	0
K121284	Chabner XRT Garments	Chabner Xrt, LLC	2013	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?

Of its descendants, K080072 (CIVCO Medical Instruments Co., Inc., 2008) has gone furthest, with 15 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?

The intended use of this device is to provide an additional aid to the fast and accurate repeat positioning of the patient for radiation or other treatment. The device forms to the back of the patient's head and eliminates the usual range of movement of ordinary head cups.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K982624 · printed Nov 5, 2026

Cite this page

510(k) Report. “K982624: Moldcare Head & Neck Cushion, Model # MT-Acl-14242.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K982624

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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