510(k) · Cleared

Cleared

AerFrame Patient Immobilization System (AFPIS)

K260792510(k) TraditionalCleared May 8, 202658-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

Stabilix, LLC · IYE Accelerator, Linear, Medical

Cleared on May 8, 2026 as substantially equivalent to K960338 (Elekta Instrument AB, 1996) after a 58-day review. Its family tree reaches back 2 generations to 1994.

Decided: May 8, 2026
Review: 58 days
Class: Class II
Product code: IYE
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K935300 (1994). 3 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK935300 Vac-Lok Immobilization SystemMedtec, Inc. · 1994
1 generation backK960338 Stereotactic Body FrameElekta Instrument AB · 1996
This deviceK260792 AerFrame Patient Immobilization System (AFPIS)Stabilix, LLC · 2026

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K935300	Vac-Lok Immobilization System	Medtec, Inc.	1994	—
−1	K960338	Stereotactic Body Frame	Elekta Instrument AB	1996	—
0 (this device)	K260792	AerFrame Patient Immobilization System (AFPIS)	Stabilix, LLC	2026	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1995	1	0

FIG. 1 — Lineage of K260792, 1994–2026Source: 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
*	K960338	Stereotactic Body Frame Summary page 5 …dicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K960338 Stereotactic Body Frame IYE…	Elekta Instrument AB	1996	—

Also cleared against K960338: 4 other devices →

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 32 years and passes through 3 companies; a new generation was cleared every 30.0 years on median.
None of the 3 ancestors has a recall.
4 other devices also cite its predicate K960338.

How does its category compare?

All IYE devices

IYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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?

Indications for Use (AerFrame™ Patient Immobilization System) The AerFrame™ Patient Immobilization System is indicated for use to aid in patient positioning and immobilization during diagnostic imaging procedures (e.g., CT and MRI) and photon-based radiotherapy. When used for radiotherapy, the system is indicated for use only in conjunction with image-guided radiotherapy (IGRT) for final patient alignment. The AerFrame system is intended for use in…

Read the full statement (207 words)

Indications for Use (AerFrame™ Patient Immobilization System)

The AerFrame™ Patient Immobilization System is indicated for use to aid in patient positioning and immobilization during diagnostic imaging procedures (e.g., CT and MRI) and photon-based radiotherapy. When used for radiotherapy, the system is indicated for use only in conjunction with image-guided radiotherapy (IGRT) for final patient alignment. The AerFrame system is intended for use in professional healthcare facilities by trained clinical staff.

Intended Patient Population / Selection Criteria:

The AerFrame system is indicated for patients who require immobilization to support repeatable positioning during CT/MRI imaging and photon-based radiotherapy workflows and who can be safely accommodated within the AerFrame and the required vacuum bag immobilization system. The system is intended for use with a compatible vacuum bag system and is not indicated for use without a vacuum bag. Maximum patient weight is 300 lb (136 kg).

Contraindications / Limitations:

No specific contraindications. The AerFrame system is not indicated for patients who exceed the maximum patient weight limit (300 lb / 136 kg) or when use of the required vacuum bag is not possible. When used for radiotherapy, the AerFrame system is not indicated for use as the sole method of final patient alignment; IGRT must be used for final alignment

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K260792 · printed Nov 6, 2026

Cite this page

510(k) Report. “K260792: AerFrame Patient Immobilization System (AFPIS).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260792

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Record history

FDA decision record loaded Oct 30, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026