510(k) · Cleared

Recalled · 2012

Integra Radionics Interfix Patient Adapters

K072454510(k) TraditionalCleared Oct 16, 200746-day reviewClass II21 CFR 892.5050Recalls 1

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

Integra Radionics, Inc. · IYE Accelerator, Linear, Medical

Cleared on Oct 16, 2007 as substantially equivalent to K924632 (Radionics, Inc., 1993) and 1 other predicate after a 46-day review. Its family tree reaches back 1 generation to 1991. It has been recalled once.

Decided: Oct 16, 2007
Review: 46 days
Class: Class II
Product code: IYE
Recalls: 1
Predicates: 2

Its longest line of descent runs back 1 generation to K912630 (1991). 2 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK912630 Xknife Radiosurgery SystemRsa, Inc. · 1991
This deviceK072454 Integra Radionics Interfix Patient AdaptersIntegra Radionics, Inc. · 2007

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K912630	Xknife Radiosurgery System	Rsa, Inc.	1991	—
0 (this device)	K072454	Integra Radionics Interfix Patient Adapters	Integra Radionics, Inc.	2007	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1993	1	0

FIG. 1 — Lineage of K072454, 1991–2007Source: 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? (2)

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
*	K924632	LCM-2-Linac Couch-Mount System Summary page 1 …e predicate devices. The technological characteristics are similar to those found with the following predicate devices: LCM-2 Linac Couch-Mount System cleared via 510(lk K924632 on April 7, 1993. Knife Radiosurgery System cleared via 510(k) K912630 on November 4, 1991. The Interfix Patient Adapters consis…	Radionics, Inc.	1993	—
*	K912630	Xknife Radiosurgery System Summary page 1 …hose found with the following predicate devices: LCM-2 Linac Couch-Mount System cleared via 510(lk K924632 on April 7, 1993. Knife Radiosurgery System cleared via 510(k) K912630 on November 4, 1991. The Interfix Patient Adapters consists of two adapters, the InterFixTM CT Adapter which attaches to the CT…	Rsa, Inc.	1991	—

What descends from it?

No later submission names this one as a predicate yet.

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jan 23, 2012	Not classified	Z-1187-2012	Device Design	Material used in the superior region of the InterFix CT Adapter (CTA) has a different density than that of the Treatment Table Couch Adapter (TTA). Resulting dosimetry can be affected if posterior fields are used. Integra estimates that a…

No ancestor or descendant has a Class I recall.

What does this lineage say?

None of the 2 ancestors has a recall.

How does its category compare?

All IYE devices

IYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?

For cranial fixation during CT scanning and treatment with the TomoTherapy HiArt System.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K072454 · printed Nov 6, 2026

Cite this page

510(k) Report. “K072454: Integra Radionics Interfix Patient Adapters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072454

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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