510(k) · Cleared

Cleared

HT-Res RTP System

K894706510(k) TraditionalCleared Oct 11, 198979-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

Adac Laboratories · IYE Accelerator, Linear, Medical

Cleared on Oct 11, 1989 after a 79-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 84 later devices descend from it.

Decided: Oct 11, 1989
Review: 79 days
Class: Class II
Product code: IYE
Recalls: None
Predicates: 0

84 later devices descend from it, 1 citing it directly.

This deviceK894706 HT-Res RTP SystemAdac Laboratories · 1989
Descendant · cites it directly · 83 of its ownK951581 PINNACLE3 ApexAdac Laboratories · 1996
Descendant · 2 generations on · 79 of its ownK993923 Adac PINNACLE3TM Radiation Therapy Planning SystemAdac Laboratories · 2000
Descendant · 3 generations on · 47 of its ownK013112 Focal SimComputerized Medical Systems, Inc. · 2001 · Recalled
Descendant · 3 generations on · 44 of its ownK032724 PINNACLE3 Radiation Therapy Planning SystemAdac Laboratories · 2003 · Recalled
Descendant · 4 generations on · 39 of its ownK041577 PINNACLE3 Radiation Therapy Planning SystemAdac Laboratories · 2004 · Recalled

Showing 5 of 84 descendants. See all descendants

Descendants cleared per year

1996high 7 (2009) · low 0 (1999)2026

Most influential descendants

Showing 5 of 84 · See all

K951581PINNACLE3 ApexAdac Laboratories · 1996 · cites it directly83descendants
K993923Adac PINNACLE3TM Radiation Therapy Planning SystemAdac Laboratories · 2000 · 2 generations on79descendants
K013112Focal SimComputerized Medical Systems, Inc. · 2001 · 3 generations on47descendants
K032724PINNACLE3 Radiation Therapy Planning SystemAdac Laboratories · 2003 · 3 generations on44descendants
K041577PINNACLE3 Radiation Therapy Planning SystemAdac Laboratories · 2004 · 4 generations on39descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K894706	HT-Res RTP System	Adac Laboratories	1989	—
+1	K951581	PINNACLE3 Apex	Adac Laboratories	1996	—
+2	K993923	Adac PINNACLE3TM Radiation Therapy Planning System	Adac Laboratories	2000	—
+3	K013112	Focal Sim	Computerized Medical Systems, Inc.	2001	10
+3	K032724	PINNACLE3 Radiation Therapy Planning System	Adac Laboratories	2003	1
+4	K041577	PINNACLE3 Radiation Therapy Planning System	Adac Laboratories	2004	7

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0
1997	1	0
1998	2	0
2000	1	0
2001	1	0
2002	2	0
2003	3	0
2004	4	0
2005	1	0
2006	6	0
2007	2	0
2008	3	0
2009	7	0
2010	4	0
2011	5	0
2012	5	0
2013	2	0
2014	3	0
2015	4	0
2016	3	0
2017	2	0
2018	4	0
2019	2	0
2020	4	0
2021	3	0
2022	2	0
2023	3	0
2024	1	0
2026	3	0

FIG. 1 — Lineage of K894706, 1989–2026Source: 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 has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (84)

See all 84

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K951581	PINNACLE3 Apex	Adac Laboratories	1996	83

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, K951581 (Adac Laboratories, 1996) has gone furthest, with 83 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/K894706 · printed Nov 6, 2026

Cite this page

510(k) Report. “K894706: HT-Res RTP System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K894706

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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