510(k) Report

510(k) · Cleared

Cleared

Swannshidi Bone Marrow Aspiration Needle

K121181510(k) TraditionalCleared Aug 22, 2012126-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

Alliance Partners, LLC · KNW Instrument, Biopsy

Cleared on Aug 22, 2012 as substantially equivalent to K061570 (Busse Hospital Disposables, Inc., 2006) and 2 other predicates after a 126-day review. Its family tree reaches back 1 generation to 2002. 6 later devices descend from it.

Decided
Aug 22, 2012
Review
126 days
Class
Class II
Product code
KNW
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K020987 (2002). 3 ancestors in all. 6 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2006: 1 other ancestor2003: 1 other ancestor2014: 1 descendant cleared2015: 1 descendant cleared2021: 1 descendant cleared2023: 1 descendant cleared2020: 1 descendant cleared2026: 1 descendant clearedK020987 · BMN I Type Marrow Aspiration Needle · H.S. Hospital Service S.R.L. · 2002200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 1 descendant2 generations forward: 1 descendant3 generations forward: 4 descendants K020987 · BMN I Type Marrow Aspiration Needle · H.S. Hospital Service S.R.L. · 20020
  1. Root · 1 generation backK020987 BMN I Type Marrow Aspiration NeedleH.S. Hospital Service S.R.L. · 2002
  2. This deviceK121181 Swannshidi Bone Marrow Aspiration NeedleAlliance Partners, LLC · 2012
  3. Descendant · cites it directly · 5 of its ownK140991 Ranfac Aspiration Needle with Adjustable GuideRanfac, Corp. · 2014
  4. Descendant · 2 generations on · 4 of its ownK150563 Marrow Cellution Bone Marrow Aspiration NeedleRanfac, Corp. · 2015
  5. Descendant · 3 generations on · 1 of its ownK223612 Ranfac Lateral Access Bone Marrow Aspiration Needle (CRVS-BMA-LA)Ranfac Corporation · 2023
  6. Descendant · 3 generations on · 1 of its ownK202287 Ran-Flex-B Bone Marrow Aspiration NeedleRanfac Corporation · 2020
  7. Descendant · 3 generations on · 0 of its ownK260572 Marrow MarxmanMedimetrix, LLC · 2026

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2014: 12015: 12020: 12021: 12023: 12026: 1
2014high 1 (2014) · low 0 (2016)2026

Most influential descendants

Showing 5 of 6 · See all
  • K140991Ranfac Aspiration Needle with Adjustable GuideRanfac, Corp. · 2014 · cites it directly5descendants
  • K150563Marrow Cellution Bone Marrow Aspiration NeedleRanfac, Corp. · 2015 · 2 generations on4descendants
  • K223612Ranfac Lateral Access Bone Marrow Aspiration Needle (CRVS-BMA-LA)Ranfac Corporation · 2023 · 3 generations on1descendant
  • K202287Ran-Flex-B Bone Marrow Aspiration NeedleRanfac Corporation · 2020 · 3 generations on1descendant
  • K260572Marrow MarxmanMedimetrix, LLC · 2026 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K020987BMN I Type Marrow Aspiration NeedleH.S. Hospital Service S.R.L.2002—
0 (this device)K121181Swannshidi Bone Marrow Aspiration NeedleAlliance Partners, LLC2012—
+1K140991Ranfac Aspiration Needle with Adjustable GuideRanfac, Corp.2014—
+2K150563Marrow Cellution Bone Marrow Aspiration NeedleRanfac, Corp.2015—
+3K223612Ranfac Lateral Access Bone Marrow Aspiration Needle (CRVS-BMA-LA)Ranfac Corporation2023—
+3K202287Ran-Flex-B Bone Marrow Aspiration NeedleRanfac Corporation2020—
+3K260572Marrow MarxmanMedimetrix, LLC2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200310
200610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201410
201510
202010
202110
202310
202610
FIG. 1 — Lineage of K121181, 2002–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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 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? (3)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K061570I-Style Bone Marrow Aspiration Needle
Summary page 1
…KNW Predicate Device: Busse Hospital Disposables I-Style Bone Marrow Aspiration Needle (K06 1570) H.S. Hospital Service S.p.A. BM4N "I"Type Marrow Bio…
Busse Hospital Disposables, Inc.2006—
*K020987BMN I Type Marrow Aspiration Needle
Summary page 1
…Aspiration Needle (K06 1570) H.S. Hospital Service S.p.A. BM4N "I"Type Marrow Biopsy Needle (K020987) Ranfac Corporation Goldenberg SNARECOIL Needle (K03…
H.S. Hospital Service S.R.L.2002—
*K031344Ranfac Goldenberg Snarecoil Soft Tissue Biopsy (GSS) Needle
Summary page 1
…Biopsy Needle (K020987) Ranfac Corporation Goldenberg SNARECOIL Needle (K03 1344) Device Description: The SwannShidi Bone Marrow Aspiration Needle consists of a 1Sga needle and an angled tip stylet of corres…
Ranfac, Corp.2003—

Also cleared against K061570: 1 other device →

What descends from it? (6)

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

NumberDeviceApplicantDecidedDescendants
K140991Ranfac Aspiration Needle with Adjustable GuideRanfac, Corp.20145

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?

  • None of the 3 ancestors has a recall.
  • Of its descendants, K140991 (Ranfac, Corp., 2014) has gone furthest, with 5 descendants of its own.
  • 1 other device also cites its predicate K061570.

How does its category compare?

All KNW devices

KNW Instrument, Biopsy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

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)—

What is it indicated for?

The SwannShidi Bone Marrow Aspiration Needle is to be used for aspiration of bone marrow or autologous blood by use of a standard syringe.

Indications for use as stated in the FDA summary.

Also cleared against K061570

1 other device cites the same predicate.

  • K120002I-Style Bone Marrow Aspiration Needle with T-HandleBusse Hospital Disposables, Inc. · 2012

More from Alliance Partners, LLC

10 FDA decisions under this applicant name. See the company

  • K201521Medina Anterior Cervical Plate SystemAlliance Partners, LLC · 2020
  • K173128Alamo® CAlliance Partners, LLC · 2018
  • K141123Alliance Spine Raas Cranial Plating SystemAlliance Partners, LLC · 2015
  • K141993Nakoma AcpAlliance Partners, LLC · 20141 recall
  • K140303Alamo TAlliance Partners, LLC · 2014

Recent decisions in KNW

The KNW category page

  • K260517Automatic Core Biopsy InstrumentZhejiang Curaway Medical Technology Co., Ltd. · 2026
  • K262571EnCor EnCompass™ Breast Biopsy and Tissue Removal SystemBard Peripheral Vascular, Inc. · 2026
  • K262792Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09)Hologic, Inc. · 2026
  • K260572Marrow MarxmanMedimetrix, LLC · 2026
  • K261196Promisemed VeriEcto Automatic Biopsy NeedlesPromisemed Hangzhou Meditech Co., Ltd. · 2026

https://510kreport.com/device/K121181 · printed Nov 6, 2026

Cite this page

510(k) Report. “K121181: Swannshidi Bone Marrow Aspiration Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121181

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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