510(k) · Cleared

Cleared

Varisource Henschke Type Gyn Applicator for Varian Varisource Remote High Dose Rate Afterloader

K980590510(k) TraditionalCleared Oct 22, 1998247-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 Medical Systems, Inc. · JAQ System, Applicator, Radionuclide, Remote-Controlled

Cleared on Oct 22, 1998 as substantially equivalent to K871217 (Mick Radio-Nuclear Instruments, Inc., 1987) after a 247-day review. Its family tree reaches back 1 generation to 1987. 7 later devices descend from it.

Decided: Oct 22, 1998
Review: 247 days
Class: Class II
Product code: JAQ
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K871217 (1987). 7 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK871217 Henschke Afterloading ApplicatorMick Radio-Nuclear Instruments, Inc. · 1987
This deviceK980590 Varisource Henschke Type Gyn Applicator for Varian Varisource Remote…Varian Medical Systems, Inc. · 1998
Descendant · cites it directly · 3 of its ownK120731 Titanium Fletcher-Style Applicator Set-Defined GeometryVarian Medical Systems, Inc. · 2012
Descendant · 2 generations on · 2 of its ownK241853 Titanium Fletcher-Style Applicator Set Defined Geometry; Smit…Varian Medical Systems, Inc. · 2024
Descendant · cites it directly · 2 of its ownK120341 Plastic Needle with Mandrin 2.0 Diameter Length 113MMVarian Medical Systems, Inc. · 2012
Descendant · 2 generations on · 1 of its ownK141624 Plastic Needle with Mandrin, 2.0 MM Diameter, Length, Blunt…Varian Medical Systems, Inc. · 2015
Descendant · 3 generations on · 0 of its ownK250299 CT/ MR Tandem and Ovoid SetVarian Medical Systems, Inc. · 2025

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2012high 2 (2012) · low 0 (2013)2026

Most influential descendants

Showing 5 of 7 · See all

K120731Titanium Fletcher-Style Applicator Set-Defined GeometryVarian Medical Systems, Inc. · 2012 · cites it directly3descendants
K241853Titanium Fletcher-Style Applicator Set Defined Geometry; Smit Cervical SleeveVarian Medical Systems, Inc. · 2024 · 2 generations on2descendants
K120341Plastic Needle with Mandrin 2.0 Diameter Length 113MMVarian Medical Systems, Inc. · 2012 · cites it directly2descendants
K141624Plastic Needle with Mandrin, 2.0 MM Diameter, Length, Blunt Tip,Plastic Needle with…Varian Medical Systems, Inc. · 2015 · 2 generations on1descendant
K250299CT/ MR Tandem and Ovoid SetVarian Medical Systems, Inc. · 2025 · 3 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K871217	Henschke Afterloading Applicator	Mick Radio-Nuclear Instruments, Inc.	1987	—
0 (this device)	K980590	Varisource Henschke Type Gyn Applicator for Varian Varisource Remote High Dose…	Varian Medical Systems, Inc.	1998	—
+1	K120731	Titanium Fletcher-Style Applicator Set-Defined Geometry	Varian Medical Systems, Inc.	2012	—
+2	K241853	Titanium Fletcher-Style Applicator Set Defined Geometry; Smit Cervical Sleeve	Varian Medical Systems, Inc.	2024	—
+1	K120341	Plastic Needle with Mandrin 2.0 Diameter Length 113MM	Varian Medical Systems, Inc.	2012	—
+2	K141624	Plastic Needle with Mandrin, 2.0 MM Diameter, Length, Blunt Tip,Plastic Needle…	Varian Medical Systems, Inc.	2015	—
+3	K250299	CT/ MR Tandem and Ovoid Set	Varian Medical Systems, Inc.	2025	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2012	2	0
2015	2	0
2024	1	0
2025	2	0

FIG. 1 — Lineage of K980590, 1987–2025Source: 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 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

Get a 510(k) Report

What was it cleared against? (1)

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
*	K871217	Henschke Afterloading Applicator Summary page 1 …ariSource Henschke Type GYN Applicator for Varian VariSource™ Remote High Dose Rate Afterioader. Mick Radio-Nuclear Instruments, Inc., Henschke Afterloading Applicator, K871217. Applicators for the Varian VariSource Remote High Dose Rate Afterloader are a part of a remote controlled radionuclide applicat…	Mick Radio-Nuclear Instruments, Inc.	1987	—

Also cleared against K871217: 1 other device →

What descends from it? (7)

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

Number	Device	Applicant	Decided	Descendants
K120731	Titanium Fletcher-Style Applicator Set-Defined Geometry	Varian Medical Systems, Inc.	2012	3
K120341	Plastic Needle with Mandrin 2.0 Diameter Length 113MM	Varian Medical Systems, Inc.	2012	2

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?

Its one ancestor has no recall.
Of its descendants, K120731 (Varian Medical Systems, Inc., 2012) has gone furthest, with 3 descendants of its own.
1 other device also cites its predicate K871217.

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	—

What is it indicated for?

The Varian VariSource™ Remote High Dose Rate Afterloader [system, including applicators and accessories] is a device intended to be used by properly trained and licensed medical personnel to provide radiation brachytherapy. The VariSource Henschke Type GYN applicator which is the subject of this 510(k) is a component of the VariSource system.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K980590 · printed Nov 6, 2026

Cite this page

510(k) Report. “K980590: Varisource Henschke Type Gyn Applicator for Varian Varisource Remote 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/K980590

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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