510(k) · Cleared

Cleared

Grac High Dose Rate (HDR) Remote Afterloading Catheter

K990753510(k) TraditionalCleared May 27, 199980-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 May 27, 1999 as substantially equivalent to K945383 (Varian Assoc., Inc., 1995) and 1 other predicate after an 80-day review. Its family tree reaches back 2 generations to 1995.

Decided: May 27, 1999
Review: 80 days
Class: Class II
Product code: JAQ
Recalls: None
Predicates: 2

Its longest line of descent runs back 2 generations to K945383 (1995). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK945383 High Dose Rate AfterloaderVarian Assoc., Inc. · 1995
1 generation backK981886 Vrac High Dose Rate (HDR) Remote Afterloading CatheterCook, Inc. · 1998
This deviceK990753 Grac High Dose Rate (HDR) Remote Afterloading CatheterCook, Inc. · 1999

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K945383	High Dose Rate Afterloader	Varian Assoc., Inc.	1995	—
−1	K981886	Vrac High Dose Rate (HDR) Remote Afterloading Catheter	Cook, Inc.	1998	—
0 (this device)	K990753	Grac High Dose Rate (HDR) Remote Afterloading Catheter	Cook, Inc.	1999	—

FIG. 1 — Lineage of K990753, 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? (2)

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 3 …ing catheters which were found substantially equivalent under VIL.3 510(k) Premarket Notification HDR Applicator Catheter COOK INCORPORATED 510(k) #D.C. K945383 and D.C. K981886. The similar indications for use and technological characteristics of the GRAC High Dose Rate (HDR) Remote After…	Varian Assoc., Inc.	1995	—
*	K981886	Vrac High Dose Rate (HDR) Remote Afterloading Catheter Summary page 3 …ch were found substantially equivalent under VIL.3 510(k) Premarket Notification HDR Applicator Catheter COOK INCORPORATED 510(k) #D.C. K945383 and D.C. K981886. The similar indications for use and technological characteristics of the GRAC High Dose Rate (HDR) Remote Afterloading Catheter…	Cook, Inc.	1998	—

Also cleared against K945383: 5 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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?

The line of descent spans 4 years and passes through 2 companies; a new generation was cleared every 3.7 years on median.
None of the 2 ancestors has a recall.
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 GammaMed 12i Remote High Dose Rate Afterloader system, supplied by Frank Barker Associates of Tuwaco, New Jersey.

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/K990753 · printed Nov 6, 2026

Cite this page

510(k) Report. “K990753: Grac 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/K990753

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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