510(k) · Cleared

Cleared

Prowess 2000

K924240510(k) TraditionalCleared May 17, 1993266-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

Small Systems Group, Inc. · IYE Accelerator, Linear, Medical

Cleared on May 17, 1993 after a 266-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 167 later devices descend from it.

Decided: May 17, 1993
Review: 266 days
Class: Class II
Product code: IYE
Recalls: None
Predicates: 0

167 later devices descend from it, 2 citing it directly.

This deviceK924240 Prowess 2000Small Systems Group, Inc. · 1993
Descendant · cites it directly · 165 of its ownK982821 MMS Therpacplus B3DTUI Model Number 6.7Multimedia Medical Systems, Inc. · 1998
Descendant · 2 generations on · 83 of its ownK030534 Variseed 7.1Varian Medical Systems · 2003 · Recalled
Descendant · 3 generations on · 79 of its ownK103576 Mim 5.2 (Brachy)Mim Software, Inc. · 2011
Descendant · 2 generations on · 79 of its ownK993923 Adac PINNACLE3TM Radiation Therapy Planning SystemAdac Laboratories · 2000
Descendant · 4 generations on · 68 of its ownK151913 MIM-Thin Client (mobile)Mim Software, Inc. · 2016

Showing 5 of 167 descendants. See all descendants

Descendants cleared per year

1998high 14 (2023) · low 1 (1998)2026

Most influential descendants

Showing 5 of 167 · See all

K982821MMS Therpacplus B3DTUI Model Number 6.7Multimedia Medical Systems, Inc. · 1998 · cites it directly165descendants
K030534Variseed 7.1Varian Medical Systems · 2003 · 2 generations on83descendants
K103576Mim 5.2 (Brachy)Mim Software, Inc. · 2011 · 3 generations on79descendants
K993923Adac PINNACLE3TM Radiation Therapy Planning SystemAdac Laboratories · 2000 · 2 generations on79descendants
K151913MIM-Thin Client (mobile)Mim Software, Inc. · 2016 · 4 generations on68descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K924240	Prowess 2000	Small Systems Group, Inc.	1993	—
+1	K982821	MMS Therpacplus B3DTUI Model Number 6.7	Multimedia Medical Systems, Inc.	1998	—
+2	K030534	Variseed 7.1	Varian Medical Systems	2003	1
+3	K103576	Mim 5.2 (Brachy)	Mim Software, Inc.	2011	—
+2	K993923	Adac PINNACLE3TM Radiation Therapy Planning System	Adac Laboratories	2000	—
+4	K151913	MIM-Thin Client (mobile)	Mim Software, Inc.	2016	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
1999	1	0
2000	1	0
2001	2	0
2002	2	0
2003	4	0
2004	4	0
2005	1	0
2006	6	0
2007	2	0
2008	3	0
2009	7	0
2010	4	0
2011	6	0
2012	5	0
2013	3	0
2014	3	0
2015	6	0
2016	5	0
2017	4	0
2018	9	0
2019	7	0
2020	9	0
2021	13	0
2022	10	0
2023	14	0
2024	10	0
2025	11	0
2026	14	0

FIG. 1 — Lineage of K924240, 1993–2026Source: 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 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

Get a 510(k) Report

What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (167)

See all 167

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

Number	Device	Applicant	Decided	Descendants
K982821	MMS Therpacplus B3DTUI Model Number 6.7	Multimedia Medical Systems, Inc.	1998	165
K982696	Interplant	Burdette Medical Systems, Inc.	1999	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, K982821 (Multimedia Medical Systems, Inc., 1998) has gone furthest, with 165 descendants of its own.

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	—

https://510kreport.com/device/K924240 · printed Nov 6, 2026

Cite this page

510(k) Report. “K924240: Prowess 2000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K924240

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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