De Novo · Granted
GrantedBreast Implant Removal Device (BIRD)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gaylord Solutions, LLC · QVS Breast Implant Suction Retrieval Device
Granted on Apr 20, 2023 as a new device type through De Novo after a 150-day review. 1 later device descends from it.
- Decided
- Apr 20, 2023
- Review
- 150 days
- Class
- Class II
- Product code
- QVS
- Recalls
- None
1 later device descends from it, 1 citing it directly.
- This deviceDEN220082 Breast Implant Removal Device (BIRD)Gaylord Solutions, LLC · 2023
- Descendant · cites it directly · 0 of its ownK252438 Explant ExpressApplied Medical Technology, Inc. · 2026
Most influential descendants
Showing 1 of 1 · See all- K252438Explant ExpressApplied Medical Technology, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN220082 | Breast Implant Removal Device (BIRD) | Gaylord Solutions, LLC | 2023 | — |
| +1 | K252438 | Explant Express | Applied Medical Technology, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 1 | 0 |
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.
Planning a device in QVS? 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 QVS device
- #1 K252438 Explant Expressscore 10.8 · 1 generation · no Class I recall
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K252438 | Explant Express | 2026 | 0 |
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, K252438 (Applied Medical Technology, Inc., 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All QVS devicesQVS Breast Implant Suction Retrieval Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · QVS
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · QVS
Too few QVS 510(k)s in any year since 2007 to give a median.
Recalls per year · QVS
No recall names QVS since 2007.
Adverse event reports per year · QVS
No MAUDE report names QVS since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Bateman™ Bottle is a single-patient, single use suction device used to assist in the removal of one intracapsular ruptured silicone breast implant.
Not intended for en bloc removal. Not intended to remove residual silicone or be applied directly to tissue.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN220082 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN220082: Breast Implant Removal Device (BIRD).” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN220082
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