510(k) · Cleared
ClearedRadial Jaw 4 Pulmonary Biopsy Forceps
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corporation · BWH Forceps, Biopsy, Bronchoscope (Non-Rigid)
Cleared on Sep 26, 2025 as substantially equivalent to K121186 (Boston Scientific Corp, 2012) after a 14-day review. Its family tree reaches back 3 generations to 1989.
- Decided
- Sep 26, 2025
- Review
- 14 days
- Class
- Class II
- Product code
- BWH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K895415 (1989). No later device cites it as a predicate yet.
- Root · 3 generations backK895415 Biopsy ForcepsSymbiosis Corp. · 1989
- 2 generations backK102336 Radial Jaw 4 Pulmonary Standard Capacity Biopsy Forceps; Radial Jaw…Boston Scientific Corporation · 2011
- 1 generation backK121186 Radial Jaw 4 Pulmonary Biopsy ForcepsBoston Scientific Corp · 2012
- This deviceK252921 Radial Jaw 4 Pulmonary Biopsy ForcepsBoston Scientific Corporation · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K895415 | Biopsy Forceps | Symbiosis Corp. | 1989 | — |
| −2 | K102336 | Radial Jaw 4 Pulmonary Standard Capacity Biopsy Forceps; Radial Jaw 4… | Boston Scientific Corporation | 2011 | — |
| −1 | K121186 | Radial Jaw 4 Pulmonary Biopsy Forceps | Boston Scientific Corp | 2012 | — |
| 0 (this device) | K252921 | Radial Jaw 4 Pulmonary Biopsy Forceps | Boston Scientific Corporation | 2025 | — |
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 BWH? 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 |
|---|---|---|---|
| * | K121186 | Radial Jaw 4 Pulmonary Biopsy ForcepsSummary page 5…Trade Name: Radial Jaw™ 4 Pulmonary Biopsy Forceps Manufacturer: Boston Scientific Corporation 510(k) Number: K121186 Classification Name: Bronchoscope (flexible or rigid) and accessories Regulation Number: 874.4680… | 2012 |
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?
- The line of descent spans 36 years and passes through 3 companies; a new generation was cleared every 13.4 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All BWH devicesBWH Forceps, Biopsy, Bronchoscope (Non-Rigid): FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · BWH
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BWH
Too few BWH 510(k)s in any year since 2007 to give a median.
Recalls per year · BWH
No recall names BWH since 2007.
Adverse event reports per year · BWH
2in 2025
MAUDE reports naming product code BWH, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 4 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 3 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 1 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
These single-use biopsy forceps are specifically designed to collect tissue endoscopically for histologic examination. These forceps should not be used for any purpose other than their intended function.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252921 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252921: Radial Jaw 4 Pulmonary Biopsy Forceps.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252921
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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