510(k) Report

510(k) · Cleared

Cleared

Applicators for Varian Varisource Remote High Soes Rate Afterloader

K952913510(k) TraditionalCleared Nov 22, 1995149-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 Nov 22, 1995 after a 149-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 18 later devices descend from it.

Decided
Nov 22, 1995
Review
149 days
Class
Class II
Product code
JAQ
Recalls
None
Predicates
0

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

Descendants, by year cleared 2002: 1 descendant cleared2007: 1 descendant cleared1996: 1 descendant cleared2018: 3 descendants cleared2012: 1 descendant cleared2016: 1 descendant cleared2009: 1 descendant cleared2008: 1 descendant cleared2014: 2 descendants cleared2019: 1 descendant cleared2006: 1 descendant cleared2004: 1 descendant cleared2020: 1 descendant cleared2017: 1 descendant cleared2022: 1 descendant cleared1995200020052010201520202025
  1. This deviceK952913 Applicators for Varian Varisource Remote High Soes Rate AfterloaderVarian Assoc., Inc. · 1995
  2. Descendant · cites it directly · 5 of its ownK113766 Clickfit Transfer Guide Tubes Needle Clickfit Transfer Guide Tubes…Varian Medical Systems, Inc. · 2012
  3. Descendant · cites it directly · 4 of its ownK955844 Applicators for Varian Varisource Remote High Dose Rate AfterloaderVarian Assoc., Inc. · 1996
  4. Descendant · 2 generations on · 3 of its ownK141336 Source Guide Tube with Locking Mechanism for 113 MM Needles…Varian Medical Systems, Inc. · 2014
  5. Descendant · cites it directly · 3 of its ownK073133 Interstitial NeedlesVarian Medical Systems, Inc. · 2007
  6. Descendant · cites it directly · 2 of its ownK181903 BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide…Varian Medical Systems, Inc. · 2018

Showing 5 of 18 descendants. See all descendants

Descendants cleared per year

1996: 12002: 12004: 12006: 12007: 12008: 12009: 12012: 12014: 22016: 12017: 12018: 32019: 12020: 12022: 1
1996high 3 (2018) · low 0 (1997)2026

Most influential descendants

Showing 5 of 18 · See all
  • K113766Clickfit Transfer Guide Tubes Needle Clickfit Transfer Guide Tubes Catheter Transfer…Varian Medical Systems, Inc. · 2012 · cites it directly5descendants
  • K955844Applicators for Varian Varisource Remote High Dose Rate AfterloaderVarian Assoc., Inc. · 1996 · cites it directly4descendants
  • K141336Source Guide Tube with Locking Mechanism for 113 MM Needles, GammamedplusVarian Medical Systems, Inc. · 2014 · 2 generations on3descendants
  • K073133Interstitial NeedlesVarian Medical Systems, Inc. · 2007 · cites it directly3descendants
  • K181903BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes, and Length…Varian Medical Systems, Inc. · 2018 · cites it directly2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K952913Applicators for Varian Varisource Remote High Soes Rate AfterloaderVarian Assoc., Inc.1995—
+1K113766Clickfit Transfer Guide Tubes Needle Clickfit Transfer Guide Tubes Catheter…Varian Medical Systems, Inc.2012—
+1K955844Applicators for Varian Varisource Remote High Dose Rate AfterloaderVarian Assoc., Inc.1996—
+2K141336Source Guide Tube with Locking Mechanism for 113 MM Needles, GammamedplusVarian Medical Systems, Inc.2014—
+1K073133Interstitial NeedlesVarian Medical Systems, Inc.2007—
+1K181903BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes…Varian Medical Systems, Inc.2018—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
200210
200410
200610
200710
200810
200910
201210
201420
201610
201710
201830
201910
202010
202210
FIG. 1 — Lineage of K952913, 1995–2022Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K241853 Titanium Fletcher-Style Applicator Set Defined…score 14.9 · 3 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #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? (18)

See all 18

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

NumberDeviceApplicantDecidedDescendants
K113766Clickfit Transfer Guide Tubes Needle Clickfit Transfer Guide Tubes Catheter Transfer…Varian Medical Systems, Inc.20125
K955844Applicators for Varian Varisource Remote High Dose Rate AfterloaderVarian Assoc., Inc.19964
K073133Interstitial NeedlesVarian Medical Systems, Inc.20073
K181903BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes, and Length…Varian Medical Systems, Inc.20182
K023220Varisource Breast Template SystemVarian Medical Systems20021
K171631Standard Catheter SetVarian Medical Systems, Inc.20180

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, K113766 (Varian Medical Systems, Inc., 2012) has gone furthest, with 5 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

2007: 112008: 102009: 102010: 22011: 22012: 72013: 62014: 72015: 112016: 62017: 72018: 72019: 22020: 42022: 12023: 22024: 102025: 62026 (partial year): 2
2007high 11 (2007) · low 0 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JAQ

91in 2025

2007: 48 days median2008: 34 days median2009: 27 days median2012: 89 days median2013: 100 days median2014: 116 days median2015: 183 days median2016: 154 days median2017: 229 days median2018: 252 days median2020: 62 days median2024: 126 days median2025: 91 days median
2007high 252 (2018) · low 27 (2009)2026

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

Recalls per year · JAQ

1in 2019

2008: 52009: 12010: 22011: 132012: 52013: 12019: 12026 (partial year): 3
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

2007: 132008: 322009: 352010: 362011: 422012: 342013: 432014: 182015: 72016: 32017: 52018: 22019: 82020: 82021: 52022: 52023: 32024: 12025: 3
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071148013
20081034532
20091027135
20102—236
20112—1342
2012789534
20136100143
20147116018
20151118307
2016615403
2017722905
2018725202
20192—18
202046208
20210—05
20221—05
20232—03
20241012601
202569103
20262—3—

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86 FDA decisions under this applicant name. See the company

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  • K992751SomavisionVarian Assoc., Inc. · 2000
  • K992753Cadplan Plus: 3D Treatment Planning SystemVarian Assoc., Inc. · 1999
  • K990085Millennium MLC -120Varian Assoc., Inc. · 19992 recalls

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https://510kreport.com/device/K952913 · printed Nov 6, 2026

Cite this page

510(k) Report. “K952913: Applicators for Varian Varisource Remote High Soes 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/K952913

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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