510(k) · Cleared

Cleared

Vrac High Dose Rate (HDR) Remote Afterloading Catheter

K981886510(k) TraditionalCleared Nov 3, 1998158-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

Cook, Inc. · JAQ System, Applicator, Radionuclide, Remote-Controlled

Cleared on Nov 3, 1998 as substantially equivalent to K945383 (Varian Assoc., Inc., 1995) after a 158-day review. Its family tree reaches back 1 generation to 1995. 1 later device descends from it.

Decided: Nov 3, 1998
Review: 158 days
Class: Class II
Product code: JAQ
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K945383 (1995). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK945383 High Dose Rate AfterloaderVarian Assoc., Inc. · 1995
This deviceK981886 Vrac High Dose Rate (HDR) Remote Afterloading CatheterCook, Inc. · 1998
Descendant · cites it directly · 0 of its ownK990753 Grac High Dose Rate (HDR) Remote Afterloading CatheterCook, Inc. · 1999

Most influential descendants

Showing 1 of 1 · See all

K990753Grac High Dose Rate (HDR) Remote Afterloading CatheterCook, Inc. · 1999 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K945383	High Dose Rate Afterloader	Varian Assoc., Inc.	1995	—
0 (this device)	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	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0

FIG. 1 — Lineage of K981886, 1995–1999Source: 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

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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
*	K945383	High Dose Rate Afterloader Summary page 1 …Rate (HDR) Remote Afterloading Catheter is similar to another COOK INCORPORATED remote afterloading catheter which was found substantially equivalent under 510(k) #D.C. K945383. The similar indications for use and technological characteristics of the VRAC High Dose Rate (HDR) Remote Afterloading Catheter…	Varian Assoc., Inc.	1995	—

Also cleared against K945383: 5 other devices →

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K990753	Grac High Dose Rate (HDR) Remote Afterloading Catheter	Cook, Inc.	1999	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?

Its one ancestor has no recall.
Of its descendants, K990753 (Cook, Inc., 1999) has gone furthest, with 0 descendants of its own.
5 other devices also cite its predicate K945383.

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?

Used for remote afterloading of a radiation source. To be used with the Varian VariSource Remote High Dose Rate Afterloader system, supplied by Varian Oncology Systems of Palo Alto, California.

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/K981886 · printed Nov 6, 2026

Cite this page

510(k) Report. “K981886: Vrac High Dose Rate (HDR) Remote Afterloading Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K981886

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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