510(k) · Cleared

Recalled · Class II · 2021

Bone-Temno/Sternum-Temno

K913306510(k) TraditionalCleared Nov 1, 199199-day reviewClass IIRecalls 5

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Proact, Ltd. · LWE Bone Marrow Collection/Transfusion Kit

Cleared on Nov 1, 1991 after a 99-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 4 later devices descend from it. It has been recalled 5 times.

Decided: Nov 1, 1991
Review: 99 days
Class: Class II
Product code: LWE
Recalls: 5
Predicates: 0

4 later devices descend from it, 1 citing it directly.

This deviceK913306 Bone-Temno/Sternum-TemnoProact, Ltd. · 1991
Descendant · cites it directly · 3 of its ownK171531 Jamshidi Bone Marrow Biopsy/Aspiration Needle, Jamshidi T-Handle…Care Fusion · 2017 · Recalled
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

Most influential descendants

Showing 4 of 4 · See all

K171531Jamshidi Bone Marrow Biopsy/Aspiration Needle, Jamshidi T-Handle Bone Marrow…Care Fusion · 2017 · cites it directly3descendants
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)	K913306	Bone-Temno/Sternum-Temno	Proact, Ltd.	1991	—
+1	K171531	Jamshidi Bone Marrow Biopsy/Aspiration Needle, Jamshidi T-Handle Bone Marrow…	Care Fusion	2017	6
+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
2017	1	0
2019	1	0
2020	1	0
2025	1	0

FIG. 1 — Lineage of K913306, 1991–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 LWE? 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

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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (4)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K171531	Jamshidi Bone Marrow Biopsy/Aspiration Needle, Jamshidi T-Handle Bone Marrow…	Care Fusion	2017	3

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Aug 24, 2021	Class II	Z-0154-2022	Process control	Due to misbranded products shipped to customers.
Feb 23, 2017	Class II	Z-1423-2018	Package design/selection	The integrity of the sterile packaging is potentially compromised.
Feb 23, 2017	Class II	Z-1425-2018	Package design/selection	The integrity of the sterile packaging is potentially compromised.
Feb 23, 2017	Class II	Z-1424-2018	Package design/selection	The integrity of the sterile packaging is potentially compromised.
Oct 18, 2010	Not classified	Z-0590-2011	Other	Outer cartons for the product may be labeled with incorrect needle gauge.

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 LWE devices

LWE Bone Marrow Collection/Transfusion Kit: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LWE

FDA has decided no LWE device since 2007.

Median 510(k) review, days · LWE

Too few LWE 510(k)s in any year since 2007 to give a median.

Recalls per year · LWE

1in 2010

2007high 1 (2010) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LWE

1in 2025

2007high 8 (2021) · low 0 (2007)2025

MAUDE reports naming product code LWE, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	0	0
2008	—	0	0
2009	—	0	0
2010	—	1	2
2011	—	0	1
2012	—	0	0
2013	—	0	1
2014	—	0	0
2015	—	0	1
2016	—	0	0
2017	—	0	2
2018	—	0	1
2019	—	0	5
2020	—	0	3
2021	—	0	8
2022	—	0	6
2023	—	0	1
2024	—	0	0
2025	—	0	1
2026	—	0	—

https://510kreport.com/device/K913306 · printed Nov 6, 2026

Cite this page

510(k) Report. “K913306: Bone-Temno/Sternum-Temno.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K913306

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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