510(k) · Cleared

Cleared

Loma Linda Univ. Proton Beam Therapy System

K872369510(k) TraditionalCleared Feb 22, 1988248-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

Loma Linda University Medical Center · IWM Synchrotron, Medical

Cleared on Feb 22, 1988 after a 248-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 47 later devices descend from it.

Decided: Feb 22, 1988
Review: 248 days
Class: Class II
Product code: IWM
Recalls: None
Predicates: 0

47 later devices descend from it, 9 citing it directly.

This deviceK872369 Loma Linda Univ. Proton Beam Therapy SystemLoma Linda University Medical Center · 1988
Descendant · cites it directly · 34 of its ownK983024 Proton Therapy SystemIon Beam Applications S.A. · 2001
Descendant · cites it directly · 27 of its ownK992414 Proton Beam Therapy System (PBTS)Optivus Technology, Inc. · 2000
Descendant · 2 generations on · 26 of its ownK053280 ProbeatHitachi, Ltd., Power Systems Group · 2006
Descendant · cites it directly · 25 of its ownK053641 Iba Proton Therapy System-Proteus 235Ion Beam Applications S.A. · 2006
Descendant · 2 generations on · 24 of its ownK060695 Iba Proton Therapy System - Proteus 235Ion Beam Applications S.A. · 2006 · Recalled

Showing 5 of 47 descendants. See all descendants

Descendants cleared per year

2000high 6 (2006) · low 0 (2002)2026

Most influential descendants

Showing 5 of 47 · See all

K983024Proton Therapy SystemIon Beam Applications S.A. · 2001 · cites it directly34descendants
K992414Proton Beam Therapy System (PBTS)Optivus Technology, Inc. · 2000 · cites it directly27descendants
K053280ProbeatHitachi, Ltd., Power Systems Group · 2006 · 2 generations on26descendants
K053641Iba Proton Therapy System-Proteus 235Ion Beam Applications S.A. · 2006 · cites it directly25descendants
K060695Iba Proton Therapy System - Proteus 235Ion Beam Applications S.A. · 2006 · 2 generations on24descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K872369	Loma Linda Univ. Proton Beam Therapy System	Loma Linda University Medical Center	1988	—
+1	K983024	Proton Therapy System	Ion Beam Applications S.A.	2001	—
+1	K992414	Proton Beam Therapy System (PBTS)	Optivus Technology, Inc.	2000	—
+2	K053280	Probeat	Hitachi, Ltd., Power Systems Group	2006	—
+1	K053641	Iba Proton Therapy System-Proteus 235	Ion Beam Applications S.A.	2006	—
+2	K060695	Iba Proton Therapy System - Proteus 235	Ion Beam Applications S.A.	2006	2

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2000	1	0
2001	2	0
2006	6	0
2007	1	0
2008	1	0
2009	2	0
2010	3	0
2012	1	0
2013	2	0
2014	3	0
2015	3	0
2016	6	0
2017	2	0
2018	1	0
2019	2	0
2020	1	0
2022	2	0
2023	2	0
2024	1	0
2025	2	0
2026	3	0

FIG. 1 — Lineage of K872369, 1988–2026Source: 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 IWM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (47)

See all 47

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

Number	Device	Applicant	Decided	Descendants
K983024	Proton Therapy System	Ion Beam Applications S.A.	2001	34
K992414	Proton Beam Therapy System (PBTS)	Optivus Technology, Inc.	2000	27
K053641	Iba Proton Therapy System-Proteus 235	Ion Beam Applications S.A.	2006	25
K082416	Iba Proton Therapy System- Proteus 235	Ion Beam Applications S.A.	2008	17
K983332	Northeast Proton Therapy Center	Massachusetts General Hospital	2001	8
K062891	Proton Therapy System	Indiana University Cyclotron Facility	2006	6
K061913	Iba Proton Therapy System - Proteus 235	Ion Beam Applications S.A.	2006	6
K120676	S-250 Proton Beam Radiation Therapy System	Mevion Medical Systems	2012	5
K083058	Iba Proton Therapy System - Proteus 235	Ion Beam Applications S.A.	2009	1

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, K983024 (Ion Beam Applications S.A., 2001) has gone furthest, with 34 descendants of its own.

How does its category compare?

All IWM devices

IWM Synchrotron, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IWM

FDA has decided no IWM device since 2007.

Median 510(k) review, days · IWM

Too few IWM 510(k)s in any year since 2007 to give a median.

Recalls per year · IWM

No recall names IWM since 2007.

Adverse event reports per year · IWM

No MAUDE report names IWM since 2007.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

https://510kreport.com/device/K872369 · printed Nov 4, 2026

Cite this page

510(k) Report. “K872369: Loma Linda Univ. Proton Beam Therapy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K872369

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Record history

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