510(k) · Cleared

Cleared

Thermoplastic Masks

K192102510(k) TraditionalCleared Sep 25, 201951-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

Aktina Medical Corporation · IYE Accelerator, Linear, Medical

Cleared on Sep 25, 2019 as substantially equivalent to K120335 (Bionix Development Corp., 2012) after a 51-day review. Its family tree reaches back 3 generations to 1994.

Decided: Sep 25, 2019
Review: 51 days
Class: Class II
Product code: IYE
Recalls: None
Predicates: 1

Its longest line of descent runs back 3 generations to K935067 (1994). No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK935067 AquaplastWfr/Aquaplast Corp. · 1994
2 generations backK022708 KlarityLarson Products, Inc. · 2002
1 generation backK120335 Embrace ThermoplasticBionix Development Corp. · 2012
This deviceK192102 Thermoplastic MasksAktina Medical Corporation · 2019

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K935067	Aquaplast	Wfr/Aquaplast Corp.	1994	—
−2	K022708	Klarity	Larson Products, Inc.	2002	—
−1	K120335	Embrace Thermoplastic	Bionix Development Corp.	2012	—
0 (this device)	K192102	Thermoplastic Masks	Aktina Medical Corporation	2019	—

FIG. 1 — Lineage of K192102, 1994–2019Source: 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? (1)

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
*	K120335	Embrace Thermoplastic Summary page 6 …device according to 21 CFR 892.5050, “Medical charged- particle radiation therapy system.” The product code is IYE. Predicate Device Embrace Thermoplastic, 510(k) No. K120335, manufactured by Bionix Development Corporation, 5154 Enterprise Blvd, Toledo, OH 43612 USA. Description This is a Traditional…	Bionix Development Corp.	2012	—

Also cleared against K120335: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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 25 years and passes through 4 companies; a new generation was cleared every 8.5 years on median.
None of the 3 ancestors has a recall.
1 other device also cites its predicate K120335.

How does its category compare?

All IYE devices

IYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.

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?

Aktina Thermoplastic Masks are medical devices used for patient positioning and immobilization during external beam radiation therapy procedures. Thermoplastic masks are intended for single patient use for the duration of the treatment.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K192102 · printed Nov 6, 2026

Cite this page

510(k) Report. “K192102: Thermoplastic Masks.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192102

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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