510(k) · Cleared

Cleared

Blocking Tray

K023636510(k) TraditionalCleared Nov 22, 200223-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

Southeastern Radiation Products, Inc. · IYE Accelerator, Linear, Medical

Cleared on Nov 22, 2002 as substantially equivalent to K913174 (Varian Assoc., Inc., 1991) and 7 other predicates after a 23-day review. Its family tree reaches back 2 generations to 1988.

Decided: Nov 22, 2002
Review: 23 days
Class: Class II
Product code: IYE
Recalls: None
Predicates: 8

Its longest line of descent runs back 2 generations to K882729 (1988). 9 ancestors in all, the oldest K833941 (1983). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK882729 Mevatron, M 2 ClassSiemens Medical Laboratories, Inc. · 1988 · Recalled
1 generation backK982513 MX MevatronSiemens Medical Solutions USA, Inc. · 1998 · Recalled
This deviceK023636 Blocking TraySoutheastern Radiation Products, Inc. · 2002

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K882729	Mevatron, M 2 Class	Siemens Medical Laboratories, Inc.	1988	38
−1	K982513	MX Mevatron	Siemens Medical Solutions USA, Inc.	1998	2
0 (this device)	K023636	Blocking Tray	Southeastern Radiation Products, Inc.	2002	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1983	1	0
1991	2	0
1994	1	0
1996	1	0
1997	1	0
1999	1	0

FIG. 1 — Lineage of K023636, 1988–2002Source: 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? (8)

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
*	K913174	Varian Clinac 600SR Summary page 1 …Blocking Tray Classification Name: Accessory to a Linac, Class I1 Predicate Device(s): Accessory to Various Linac Manufacturers including: Varian K913174 K913119 Siemens K9825 13 Philips (Elekta) K963624 GEKGR…	Varian Assoc., Inc.	1991	—
*	K913119	Varian C-Series Clinacs (Clinac 2300C/D) Summary page 1 …Name: Accessory to a Linac, Class I1 Predicate Device(s): Accessory to Various Linac Manufacturers including: Varian K913174 K913119 Siemens K9825 13 Philips (Elekta) K963624 GEKGR K833941 Mitsubishi…	Varian Assoc., Inc.	1991	6
*	K982513	MX Mevatron Summary page 2 …ate Device(s): Accessory to Various Linac Manufacturers including: Varian K913174 K913119 Siemens K9825 13 Philips (Elekta) K963624 GEKGR K833941 Mitsubishi K970137 Mick-Radio K99 1107…	Siemens Medical Solutions USA, Inc.	1998	2
*	K963624	Philips Sli Series Linear Accelerator Summary page 2 …ous Linac Manufacturers including: Varian K913174 K913119 Siemens K9825 13 Philips (Elekta) K963624 GEKGR K833941 Mitsubishi K970137 Mick-Radio K99 1107 Med-Tec Inc K9443 15…	Philips Medical Systems, Inc.	1996	2
*	K833941	ORION Summary page 2 …g: Varian K913174 K913119 Siemens K9825 13 Philips (Elekta) K963624 GEKGR K833941 Mitsubishi K970137 Mick-Radio K99 1107 Med-Tec Inc K9443 15 Intended Use: Blocking Trays…	Cgr Medical Corp.	1983	—
*	K970137	Exl-12SP,12DP,15DP,20DP Linac Summary page 2 …74 K913119 Siemens K9825 13 Philips (Elekta) K963624 GEKGR K833941 Mitsubishi K970137 Mick-Radio K99 1107 Med-Tec Inc K9443 15 Intended Use: Blocking Trays are to be used as an accessory t…	Mitsubishi Electronics America, Inc.	1997	—
*	K991107	Shadow Trays Summary page 2 …9 Siemens K9825 13 Philips (Elekta) K963624 GEKGR K833941 Mitsubishi K970137 Mick-Radio K99 1107 Med-Tec Inc K9443 15 Intended Use: Blocking Trays are to be used as an accessory to a Linac. Custom blocks are moun…	Mick Radio-Nuclear Instruments, Inc.	1999	—
*	K944315	Blocking Tray Summary page 2 …K9825 13 Philips (Elekta) K963624 GEKGR K833941 Mitsubishi K970137 Mick-Radio K99 1107 Med-Tec Inc K9443 15 Intended Use: Blocking Trays are to be used as an accessory to a Linac. Custom blocks are mounted onto Blocking trays and slid…	Medtec, Inc.	1994	—

Also cleared against K913174: 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 14 years and passes through 3 companies; a new generation was cleared every 9.9 years on median.
4 of the 9 ancestors have a recall of any class.
1 other device also cites its predicate K913174.

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?

This device is intended for mounting blocks andor compensators/modulators for insertion into a Linear Accelerator head.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K023636 · printed Nov 5, 2026

Cite this page

510(k) Report. “K023636: Blocking Tray.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K023636

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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