510(k) · Cleared
ClearedBRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes, and Length Assessment Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Varian Medical Systems, Inc. · JAQ System, Applicator, Radionuclide, Remote-Controlled
Cleared on Oct 3, 2018 as substantially equivalent to K120993 (Varian Medical Systems, Inc., 2012) and 2 other predicates after a 79-day review. Its family tree reaches back 5 generations to 1986. 2 later devices descend from it.
- Decided
- Oct 3, 2018
- Review
- 79 days
- Class
- Class II
- Product code
- JAQ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K864210 (1986). 13 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK864210 Microselectron-HDR (High Dose Rate)Nucletron-Oldelft Corp. · 1986
- 4 generations backK953946 Microselectron-HDR Version 2Nucletron-Oldelft Corp. · 1996
- 3 generations backK041933 Microselectron PDRNucletron Corp. · 2004
- 2 generations backK061354 Microselectron V3, Model 106.990Nucletron Corporation · 2006
- 1 generation backK120993 Gammamedplus IX Brachytherapy Afterloader, Gammamedplus 3/24 IX…Varian Medical Systems, Inc. · 2012
- This deviceK181903 BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide…Varian Medical Systems, Inc. · 2018
- Descendant · cites it directly · 1 of its ownK191580 BRAVOS Afterloader System, Transfer Guide Tubes, Length Assessment…Varian Medical Systems, Inc. · 2019
- Descendant · 2 generations on · 0 of its ownK221797 BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide…Varian Medical Systems, Inc. · 2022
Most influential descendants
Showing 2 of 2 · See all- K191580BRAVOS Afterloader System, Transfer Guide Tubes, Length Assessment DeviceVarian Medical Systems, Inc. · 2019 · cites it directly1descendant
- K221797BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes and Length…Varian Medical Systems, Inc. · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K864210 | Microselectron-HDR (High Dose Rate) | Nucletron-Oldelft Corp. | 1986 | — |
| −4 | K953946 | Microselectron-HDR Version 2 | Nucletron-Oldelft Corp. | 1996 | — |
| −3 | K041933 | Microselectron PDR | Nucletron Corp. | 2004 | — |
| −2 | K061354 | Microselectron V3, Model 106.990 | Nucletron Corporation | 2006 | — |
| −1 | K120993 | Gammamedplus IX Brachytherapy Afterloader, Gammamedplus 3/24 IX Brachytherapy… | Varian Medical Systems, Inc. | 2012 | — |
| 0 (this device) | K181903 | BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes… | Varian Medical Systems, Inc. | 2018 | — |
| +1 | K191580 | BRAVOS Afterloader System, Transfer Guide Tubes, Length Assessment Device | Varian Medical Systems, Inc. | 2019 | — |
| +2 | K221797 | BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes and… | Varian Medical Systems, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 2003 | 1 | 0 |
| 2007 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
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
What was it cleared against? (3)
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 | Decided |
|---|---|---|---|
| * | K120993 | Gammamedplus IX Brachytherapy Afterloader, Gammamedplus 3/24 IX Brachytherapy AfterloaderSummary page 5…Classification Name: Predicate Devices: Remote controlled radionuclide applicator system, 21 CFR §892.5700 (K120993) GammaMedplus iX Series Common/Usual Name:… | 2012 |
| * | K141336 | Source Guide Tube with Locking Mechanism for 113 MM Needles, GammamedplusSummary page 5…20993) GammaMedplus iX Series Common/Usual Name: (K141336) Afterloader System GammaMedplus Source Guide Tubes… | 2014 |
| * | K952913 | Applicators for Varian Varisource Remote High Soes Rate AfterloaderSummary page 5…GammaMedplus Source Guide Tubes Source Guide Tubes Brachytherapy Accessory (K952913) Applicators for Varian VariSource Remote HDR Regulatory Clas… | 1995 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K191580 | BRAVOS Afterloader System, Transfer Guide Tubes, Length Assessment Device | 2019 | 1 |
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 32 years and passes through 4 companies; a new generation was cleared every 6.2 years on median.
- 3 of the 13 ancestors have a recall of any class.
- Of its descendants, K191580 (Varian Medical Systems, Inc., 2019) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K120993.
How does its category compare?
All JAQ devicesJAQ System, Applicator, Radionuclide, Remote-Controlled: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · JAQ
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JAQ
91in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JAQ
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JAQ
3in 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 BRAVOS Afterloader System is intended for use in the treatment of both benign and malignant disease or other conditions, for both curative and palliative intent, in the delivery of remote-controlled High Dose Rate (HDR) brachytherapy. The Transfer Guide Tubes are intended to connect between the BRAVOS Remote Afterloader system and its range of Applicators. This connection creates a conduit for the source cable to travel through and allows the…
Read the full statement (108 words)
The BRAVOS Afterloader System is intended for use in the treatment of both benign and malignant disease or other conditions, for both curative and palliative intent, in the delivery of remote-controlled High Dose Rate (HDR) brachytherapy.
The Transfer Guide Tubes are intended to connect between the BRAVOS Remote Afterloader system and its range of Applicators. This connection creates a conduit for the source cable to travel through and allows the radioactive isotopes to be positioned within the patient’s tumor site.
The Length Assessment Device is intended to allow the user to establish an approximate length of an unknown length channel prior to the afterloader performing definitive length verification.
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/K181903 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181903: BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes, and Length Assessment Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181903
Report an extraction error
Are you the manufacturer?
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