510(k) · Cleared
ClearedExplant Express
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Applied Medical Technology, Inc. · QVS Breast Implant Suction Retrieval Device
Cleared on Feb 3, 2026 as substantially equivalent to DEN220082 (Gaylord Solutions, LLC, 2023) after a 186-day review. Its family tree reaches back 1 generation to 2023.
- Decided
- Feb 3, 2026
- Review
- 186 days
- Class
- Class II
- Product code
- QVS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN220082 (2023). No later device cites it as a predicate yet.
- Root · 1 generation backDEN220082 Breast Implant Removal Device (BIRD)Gaylord Solutions, LLC · 2023
- This deviceK252438 Explant ExpressApplied Medical Technology, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN220082 | Breast Implant Removal Device (BIRD) | Gaylord Solutions, LLC | 2023 | — |
| 0 (this device) | K252438 | Explant Express | Applied Medical Technology, Inc. | 2026 | — |
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 QVS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | DEN220082 | Breast Implant Removal Device (BIRD)Summary page 5…QVS III. IDENTIFICATION OF PREDICATE: Trade/Device Name: BIRD (previously known as the Bateman Bottle) Manufacturer: Gaylord Solutions LLC DeNovo Classification No: DEN220082 The predicate device has not been subject to any design-related recalls. No reference devices were used in this submission. IV… | 2023 |
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.
What does this lineage say?
- Its one ancestor has no recall.
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. 2026, 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 Explant Express T M 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/K252438 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252438: Explant Express.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252438
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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