510(k) · Cleared
ClearedRadial Jaw 4 Pulmonary Standard Capacity Biopsy Forceps; Radial Jaw 4 Pulmonary Standard Capacity Biopsy Forceps with NE
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 Jan 24, 2011 as substantially equivalent to K895415 (Symbiosis Corp., 1989) after a 159-day review. Its family tree reaches back 1 generation to 1989. 2 later devices descend from it.
- Decided
- Jan 24, 2011
- Review
- 159 days
- Class
- Class II
- Product code
- BWH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K895415 (1989). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK895415 Biopsy ForcepsSymbiosis Corp. · 1989
- This deviceK102336 Radial Jaw 4 Pulmonary Standard Capacity Biopsy Forceps; Radial Jaw…Boston Scientific Corporation · 2011
- Descendant · cites it directly · 1 of its ownK121186 Radial Jaw 4 Pulmonary Biopsy ForcepsBoston Scientific Corp · 2012
- Descendant · 2 generations on · 0 of its ownK252921 Radial Jaw 4 Pulmonary Biopsy ForcepsBoston Scientific Corporation · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K895415 | Biopsy Forceps | Symbiosis Corp. | 1989 | — |
| 0 (this device) | 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 | — |
| +2 | K252921 | Radial Jaw 4 Pulmonary Biopsy Forceps | Boston Scientific Corporation | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2025 | 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 BWH? 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 BWH device
- #1 K252921 Radial Jaw 4 Pulmonary Biopsy Forcepsscore 10.7 · 3 generations · no Class I recall
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 |
|---|---|---|---|
| * | K895415 | Biopsy ForcepsSummary page 1…Regulation Number: 874.4680 Product Code: BWH Classification: Class 11 3. Predicate Device: Boston Scientific Radial Jaw7 "1 Pulmonary Biopsy Forceps (K895415) Boston Scientific Radial Jaw"" 3 Pulmonary Biopsy Forceps (K8954 15) 4. Proposed Device Description: The Radial JawTr'l 4 Pu… | 1989 |
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 |
|---|---|---|---|
| K121186 | Radial Jaw 4 Pulmonary Biopsy Forceps | 2012 | 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?
- Its one ancestor has no recall.
- Of its descendants, K121186 (Boston Scientific Corp, 2012) has gone furthest, with 1 descendant of its own.
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. 2011, 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?
The Radial Jaw 4 Pulmonary Biopsy Forceps are specifically designed to collect tissue encloscopically for histologic examination. These instruments should not be used for any pups other thani their intended use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102336 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102336: Radial Jaw 4 Pulmonary Standard Capacity Biopsy Forceps; Radial Jaw 4 Pulmonary Standard Capacity Biopsy Forceps with NE.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102336
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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