510(k) · Cleared

Cleared

High Dose Rate Afterloader

K945383510(k) TraditionalCleared Feb 15, 1995113-day reviewClass II21 CFR 892.5700

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

Varian Assoc., Inc. · JAQ System, Applicator, Radionuclide, Remote-Controlled

Cleared on Feb 15, 1995 after a 113-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 27 later devices descend from it.

Decided: Feb 15, 1995
Review: 113 days
Class: Class II
Product code: JAQ
Recalls: None
Predicates: 0

27 later devices descend from it, 6 citing it directly.

This deviceK945383 High Dose Rate AfterloaderVarian Assoc., Inc. · 1995
Descendant · cites it directly · 20 of its ownK992577 Photon Radiosurgery System (PRS)Photoelectron Corporation · 1999
Descendant · 2 generations on · 9 of its ownK051055 Intrabeam SystemCarl Zeiss Surgical GmbH · 2005 · Recalled
Descendant · 2 generations on · 8 of its ownK121653 Intrabeam System with Intrabeam Spherical ApplicatorsCarl Zeiss Meditec, Inc. · 2012 · Recalled
Descendant · cites it directly · 8 of its ownK061582 Varisource 200 HDR AfterloaderVarian Medical Systems, Inc. · 2006
Descendant · cites it directly · 8 of its ownK050843 Axxent Electronic Brachytherapy SystemXoft, Inc. · 2005

Showing 5 of 27 descendants. See all descendants

Descendants cleared per year

1996high 3 (2016) · low 0 (1997)2026

Most influential descendants

Showing 5 of 27 · See all

K992577Photon Radiosurgery System (PRS)Photoelectron Corporation · 1999 · cites it directly20descendants
K051055Intrabeam SystemCarl Zeiss Surgical GmbH · 2005 · 2 generations on9descendants
K121653Intrabeam System with Intrabeam Spherical ApplicatorsCarl Zeiss Meditec, Inc. · 2012 · 2 generations on8descendants
K061582Varisource 200 HDR AfterloaderVarian Medical Systems, Inc. · 2006 · cites it directly8descendants
K050843Axxent Electronic Brachytherapy SystemXoft, Inc. · 2005 · cites it directly8descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K945383	High Dose Rate Afterloader	Varian Assoc., Inc.	1995	—
+1	K992577	Photon Radiosurgery System (PRS)	Photoelectron Corporation	1999	—
+2	K051055	Intrabeam System	Carl Zeiss Surgical GmbH	2005	2
+2	K121653	Intrabeam System with Intrabeam Spherical Applicators	Carl Zeiss Meditec, Inc.	2012	2
+1	K061582	Varisource 200 HDR Afterloader	Varian Medical Systems, Inc.	2006	—
+1	K050843	Axxent Electronic Brachytherapy System	Xoft, Inc.	2005	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0
1998	1	0
1999	2	0
2005	2	0
2006	1	0
2007	1	0
2008	1	0
2009	1	0
2011	1	0
2012	2	0
2013	2	0
2014	1	0
2016	3	0
2017	1	0
2018	1	0
2019	3	0
2022	1	0
2024	1	0
2025	1	0

FIG. 1 — Lineage of K945383, 1995–2025Source: 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 JAQ? 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 JAQ device

#1 K241853 Titanium Fletcher-Style Applicator Set Defined…score 14.9 · 3 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?

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

What descends from it? (27)

See all 27

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

Number	Device	Applicant	Decided	Descendants
K992577	Photon Radiosurgery System (PRS)	Photoelectron Corporation	1999	20
K061582	Varisource 200 HDR Afterloader	Varian Medical Systems, Inc.	2006	8
K050843	Axxent Electronic Brachytherapy System	Xoft, Inc.	2005	8
K981886	Vrac High Dose Rate (HDR) Remote Afterloading Catheter	Cook, Inc.	1998	1
K990753	Grac High Dose Rate (HDR) Remote Afterloading Catheter	Cook, Inc.	1999	0
K954467	Cadplan BT	Varian Assoc., Inc.	1996	0

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, K992577 (Photoelectron Corporation, 1999) has gone furthest, with 20 descendants of its own.

How does its category compare?

All JAQ devices

JAQ System, Applicator, Radionuclide, Remote-Controlled: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JAQ

6in 2025

2007high 11 (2007) · low 0 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JAQ

91in 2025

2007high 252 (2018) · low 27 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JAQ

1in 2019

2007high 13 (2011) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JAQ

3in 2025

2007high 43 (2013) · low 1 (2024)2025

MAUDE reports naming product code JAQ, 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	11	48	0	13
2008	10	34	5	32
2009	10	27	1	35
2010	2	—	2	36
2011	2	—	13	42
2012	7	89	5	34
2013	6	100	1	43
2014	7	116	0	18
2015	11	183	0	7
2016	6	154	0	3
2017	7	229	0	5
2018	7	252	0	2
2019	2	—	1	8
2020	4	62	0	8
2021	0	—	0	5
2022	1	—	0	5
2023	2	—	0	3
2024	10	126	0	1
2025	6	91	0	3
2026	2	—	3	—

https://510kreport.com/device/K945383 · printed Nov 6, 2026

Cite this page

510(k) Report. “K945383: High Dose Rate Afterloader.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K945383

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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