510(k) · Cleared

Recalled · 2011

Gammamed 12I

K891131510(k) TraditionalCleared Aug 7, 1989157-day reviewClass II21 CFR 892.5700Recalls 4

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

Mick Radio-Nuclear Instruments, Inc. · JAQ System, Applicator, Radionuclide, Remote-Controlled

Cleared on Aug 7, 1989 after a 157-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 10 later devices descend from it. It has been recalled 4 times.

Decided: Aug 7, 1989
Review: 157 days
Class: Class II
Product code: JAQ
Recalls: 4
Predicates: 0

10 later devices descend from it, 2 citing it directly.

This deviceK891131 Gammamed 12IMick Radio-Nuclear Instruments, Inc. · 1989
Descendant · cites it directly · 7 of its ownK030745 Gammamed 212 and 232 Source AssemblyVarian Medical Systems · 2003
Descendant · 2 generations on · 4 of its ownK042864 Implant Sciences Corp, Model HDR-4140Implant Sciences Corp. · 2005
Descendant · 3 generations on · 1 of its ownK090366 Spec Model M-31Source Production & Equipment Co., Inc. · 2009
Descendant · cites it directly · 1 of its ownK063815 Varian Esophagus Bougie ApplicatorVarian Medical Systems · 2007
Descendant · 2 generations on · 1 of its ownK052947 Source Production & Equipment CO, Inc., Model M-19 IR-192…Source Production & Equipment Co., Inc. · 2006 · Recalled

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2003high 2 (2007) · low 0 (2004)2026

Most influential descendants

Showing 5 of 10 · See all

K030745Gammamed 212 and 232 Source AssemblyVarian Medical Systems · 2003 · cites it directly7descendants
K042864Implant Sciences Corp, Model HDR-4140Implant Sciences Corp. · 2005 · 2 generations on4descendants
K090366Spec Model M-31Source Production & Equipment Co., Inc. · 2009 · 3 generations on1descendant
K063815Varian Esophagus Bougie ApplicatorVarian Medical Systems · 2007 · cites it directly1descendant
K052947Source Production & Equipment CO, Inc., Model M-19 IR-192 Brachytherapy SourceSource Production & Equipment Co., Inc. · 2006 · 2 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K891131	Gammamed 12I	Mick Radio-Nuclear Instruments, Inc.	1989	—
+1	K030745	Gammamed 212 and 232 Source Assembly	Varian Medical Systems	2003	—
+2	K042864	Implant Sciences Corp, Model HDR-4140	Implant Sciences Corp.	2005	—
+3	K090366	Spec Model M-31	Source Production & Equipment Co., Inc.	2009	—
+1	K063815	Varian Esophagus Bougie Applicator	Varian Medical Systems	2007	—
+2	K052947	Source Production & Equipment CO, Inc., Model M-19 IR-192 Brachytherapy Source	Source Production & Equipment Co., Inc.	2006	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2005	1	0
2006	1	0
2007	2	0
2008	1	0
2009	2	0
2014	1	0
2016	1	0

FIG. 1 — Lineage of K891131, 1989–2016Source: 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

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? (10)

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

Number	Device	Applicant	Decided	Descendants
K030745	Gammamed 212 and 232 Source Assembly	Varian Medical Systems	2003	7
K063815	Varian Esophagus Bougie Applicator	Varian Medical Systems	2007	1

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Oct 6, 2011	Not classified	Z-0329-2012	Device Design	The Product Models 1 & 2 have a design flaw problem where the clamping adapter can obstruct movement of the source cable in the event the bronchial catheter is dislodged from the connector.
Oct 6, 2011	Not classified	Z-0330-2012	Device Design	The Product Models 1 & 2 have a design flaw problem where the clamping adapter can obstruct movement of the source cable in the event the bronchial catheter is dislodged from the connector.
Sep 11, 2006	Not classified	Z-0486-2007	Other	Medical device for patient treatment does not meet electrical safety standards.
May 1, 2006	Not classified	Z-1398-06	Other	Software control program for a medical device used in radiation treatment may cause practitioners to incorrectly administer the treatment plan to cancer patients. There is a hazard when entering the treatment plans manually that the user…

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K030745 (Varian Medical Systems, 2003) has gone furthest, with 7 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/K891131 · printed Nov 6, 2026

Cite this page

510(k) Report. “K891131: Gammamed 12I.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K891131

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026