510(k) Report

510(k) · Cleared

Cleared

Jamshidi Marrow Acquisition Cradle

K003370510(k) SpecialCleared Nov 22, 200023-day reviewClass II21 CFR 876.1075

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

Allegiance Healthcare Corp. · KNW Instrument, Biopsy

Cleared on Nov 22, 2000 after a 23-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.

Decided
Nov 22, 2000
Review
23 days
Class
Class II
Product code
KNW
Recalls
None
Predicates
0

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

Descendants, by year cleared 2017: 1 descendant cleared2025: 1 descendant cleared2020: 1 descendant cleared2019: 1 descendant cleared200020052010201520202025
  1. This deviceK003370 Jamshidi Marrow Acquisition CradleAllegiance Healthcare Corp. · 2000
  2. Descendant · cites it directly · 3 of its ownK171531 Jamshidi Bone Marrow Biopsy/Aspiration Needle, Jamshidi T-Handle…Care Fusion · 2017 · Recalled
  3. Descendant · 2 generations on · 0 of its ownK242322 Bone Marrow Biopsy NeedleZhejiang Curaway Medical Technology Co., Ltd. · 2025
  4. Descendant · 2 generations on · 0 of its ownK192099 MED-I Bone Marrow Aspiration Needle, MED-S Bone Marrow Aspiration…Medax Srl Unipersonale · 2020
  5. 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

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K003370Jamshidi Marrow Acquisition CradleAllegiance Healthcare Corp.2000—
+1K171531Jamshidi Bone Marrow Biopsy/Aspiration Needle, Jamshidi T-Handle Bone Marrow…Care Fusion20176
+2K242322Bone Marrow Biopsy NeedleZhejiang Curaway Medical Technology Co., Ltd.2025—
+2K192099MED-I Bone Marrow Aspiration Needle, MED-S Bone Marrow Aspiration Needle…Medax Srl Unipersonale2020—
+2K190177J-Type Marrow Biopsy Needle,T-Type Marrow Biopsy Needle,Tweezer Bone Marrow…Ranfac Corporation2019—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201710
201910
202010
202510
FIG. 1 — Lineage of K003370, 2000–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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 KNW? 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 KNW device

  1. #1 K260572 Marrow Marxmanscore 14.5 · 10 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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? (4)

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

NumberDeviceApplicantDecidedDescendants
K171531Jamshidi Bone Marrow Biopsy/Aspiration Needle, Jamshidi T-Handle Bone Marrow…Care Fusion20173

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?

  • Of its descendants, K171531 (Care Fusion, 2017) has gone furthest, with 3 descendants of its own.

How does its category compare?

All KNW devices

KNW Instrument, Biopsy: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KNW

12in 2025

2007: 62008: 42009: 62010: 32011: 102012: 72013: 32014: 82015: 102016: 92017: 82018: 72019: 52020: 82021: 92022: 82023: 72024: 52025: 122026 (partial year): 7
2007high 12 (2025) · low 3 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KNW

178in 2025

2007: 94 days median2008: 53 days median2009: 35 days median2010: 57 days median2011: 64 days median2012: 94 days median2013: 100 days median2014: 95 days median2015: 106 days median2016: 127 days median2017: 90 days median2018: 71 days median2019: 94 days median2020: 92 days median2021: 54 days median2022: 203 days median2023: 164 days median2024: 114 days median2025: 178 days median2026 (partial year): 29 days median
2007high 203 (2022) · low 35 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KNW

1in 2024

2007: 12008: 72009: 32010: 22011: 52012: 12013: 1, 1 Class I2014: 32016: 52017: 12019: 42021: 32022: 32023: 22024: 12026 (partial year): 4, 3 Class I
2007high 7 (2008) · low 0 (2015)2026

Class I (4 since 2007) Class II/III not classified

Adverse event reports per year · KNW

1,667in 2025

2007: 7662008: 3632009: 3512010: 1622011: 672012: 932013: 982014: 1932015: 5912016: 2972017: 7602018: 1,0122019: 4,1952020: 5,1202021: 1,0202022: 5352023: 9312024: 1,2832025: 1,667
2007high 5,120 (2020) · low 67 (2011)2025

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

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20076941766
20084537363
20096353351
20103572162
20111064567
2012794193
201331001 (1)98
20148953193
2015101060591
201691275297
20178901760
201877101,012
201959444,195
202089205,120
202195431,020
202282033535
202371642931
2024511411,283
20251217801,667
20267294 (3)—
Cite this page

510(k) Report. “K003370: Jamshidi Marrow Acquisition Cradle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003370

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026