510(k) · Cleared
Recalled · Class II · 2026Biopsy Needles & Trays
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
American Pharmaseal Div. Ahsc · FSH Tray, Surgical, Needle
Cleared on Jan 28, 1982 after a 65-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it. It has been recalled 2 times.
- Decided
- Jan 28, 1982
- Review
- 65 days
- Class
- Class I
- Product code
- FSH
- Recalls
- 2
- Predicates
- 0
6 later devices descend from it, 2 citing it directly.
- This deviceK813338 Biopsy Needles & TraysAmerican Pharmaseal Div. Ahsc · 1982
- Descendant · cites it directly · 3 of its ownK171531 Jamshidi Bone Marrow Biopsy/Aspiration Needle, Jamshidi T-Handle…Care Fusion · 2017 · Recalled
- Descendant · cites it directly · 1 of its ownK961185 Daum BiopsyneedleFerguson Medical · 1996
- Descendant · 2 generations on · 0 of its ownK242322 Bone Marrow Biopsy NeedleZhejiang Curaway Medical Technology Co., Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK192099 MED-I Bone Marrow Aspiration Needle, MED-S Bone Marrow Aspiration…Medax Srl Unipersonale · 2020
- Descendant · 2 generations on · 0 of its ownK190177 J-Type Marrow Biopsy Needle,T-Type Marrow Biopsy Needle,Tweezer Bone…Ranfac Corporation · 2019
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K171531Jamshidi Bone Marrow Biopsy/Aspiration Needle, Jamshidi T-Handle Bone Marrow…Care Fusion · 2017 · cites it directly3descendants
- K961185Daum BiopsyneedleFerguson Medical · 1996 · cites it directly1descendant
- K242322Bone Marrow Biopsy NeedleZhejiang Curaway Medical Technology Co., Ltd. · 2025 · 2 generations on0descendants
- K192099MED-I Bone Marrow Aspiration Needle, MED-S Bone Marrow Aspiration Needle, MED-L Bone…Medax Srl Unipersonale · 2020 · 2 generations on0descendants
- K190177J-Type Marrow Biopsy Needle,T-Type Marrow Biopsy Needle,Tweezer Bone Marrow Biopsy Needle,Ranfac Corporation · 2019 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K813338 | Biopsy Needles & Trays | American Pharmaseal Div. Ahsc | 1982 | — |
| +1 | K171531 | Jamshidi Bone Marrow Biopsy/Aspiration Needle, Jamshidi T-Handle Bone Marrow… | Care Fusion | 2017 | 6 |
| +1 | K961185 | Daum Biopsyneedle | Ferguson Medical | 1996 | — |
| +2 | K242322 | Bone Marrow Biopsy Needle | Zhejiang Curaway Medical Technology Co., Ltd. | 2025 | — |
| +2 | K192099 | MED-I Bone Marrow Aspiration Needle, MED-S Bone Marrow Aspiration Needle… | Medax Srl Unipersonale | 2020 | — |
| +2 | K190177 | J-Type Marrow Biopsy Needle,T-Type Marrow Biopsy Needle,Tweezer Bone Marrow… | Ranfac Corporation | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FSH? 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (6)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 21, 2026 | Class II | Z-2668-2026 | Nonconforming Material/Component | Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier. |
| Feb 23, 2017 | Class II | Z-1422-2018 | Package design/selection | The integrity of the sterile packaging is potentially compromised. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K171531 (Care Fusion, 2017) has gone furthest, with 3 descendants of its own.
How does its category compare?
All FSH devicesFSH Tray, Surgical, Needle: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FSH
FDA has decided no FSH device since 2007.
Median 510(k) review, days · FSH
Too few FSH 510(k)s in any year since 2007 to give a median.
Recalls per year · FSH
1so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FSH
3in 2025
MAUDE reports naming product code FSH, 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 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 2 |
| 2012 | 0 | — | 0 | 5 |
| 2013 | 0 | — | 0 | 5 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 0 | — | 0 | 4 |
| 2016 | 0 | — | 0 | 5 |
| 2017 | 0 | — | 0 | 18 |
| 2018 | 0 | — | 0 | 9 |
| 2019 | 0 | — | 0 | 4 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 1 | — |
https://510kreport.com/device/K813338 · printed Nov 6, 2026
Cite this page
510(k) Report. “K813338: Biopsy Needles & Trays.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K813338
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026