BrachyGel Vaginal Hydrogel Packing System

DEN220052De NovoGranted Aug 22, 2023362-day reviewClass II21 CFR 892.5735

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

Brachyfoam, Inc. D/B/A Advaray · QXR Vaginal Hydrogel Packing System

Granted on Aug 22, 2023 as a new device type through De Novo after a 362-day review.

Decided: Aug 22, 2023
Review: 362 days
Class: Class II
Product code: QXR
Recalls: None

De Novo grants create a new device type without a predicate, so this family tree starts here.

FIG. 1 — Lineage of DEN220052Source: FDA De Novo database · How lineage is built

Sources: FDA De Novo 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.

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Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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Does it have a predicate?

De Novo decisions do not claim a predicate device.

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.

How does its category compare?

All QXR devices

QXR Vaginal Hydrogel Packing System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.

FDA decisions per year · QXR

1in 2023

2007high 1 (2023) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QXR

Too few QXR 510(k)s in any year since 2007 to give a median.

Recalls per year · QXR

No recall names QXR since 2007.

Adverse event reports per year · QXR

No MAUDE report names QXR since 2007.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	0	—	0
2018	0	—	0
2019	0	—	0
2020	0	—	0
2021	0	—	0
2022	0	—	0
2023	1	—	0
2024	0	—	0
2025	0	—	0
2026	0	—	—

What is it indicated for?

Read the full statement (140 words)

The BrachyGel Vaginal Hydrogel Packing System is a single-use, non-sterile, disposable, non-powered positioning device that delivers self-expanding hydrogel that forms and expands within the vaginal cavity. The purpose of this device is to displace the vaginal wall and adjacent pelvic tissues during radiation therapy planning and delivery, to reduce dose to adjacent tissues by attenuation of radiation dose, and to stabilize radiation treatment equipment during radiation therapy planning and delivery. The placement of the hydrogel device requires a physician or physician directed healthcare professional, and is performed as a separate procedure outside of brachytherapy applicator insertion, computed tomography and/or magnetic resonance imaging exam, radiation treatment planning and radiation treatment delivery. This device is not intended to be inserted into the uterine cavity or rectum. This device is intended to be in place temporarily and removed after less than 24 hours.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/DEN220052 · printed Nov 6, 2026

Cite this page

510(k) Report. “DEN220052: BrachyGel Vaginal Hydrogel Packing System.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN220052

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Page last updated Nov 3, 2026