510(k) Report

510(k) · Cleared

Cleared

Marromax B One Marrow Aspiration Needle Kit, Models 50083-XX, 50084-XX

K100665510(k) AbbreviatedCleared Jun 24, 2010108-day reviewClass II21 CFR 880.5860

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

Needle Tech Products, Inc. · FMF Syringe, Piston

Cleared on Jun 24, 2010 after a 108-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 13 later devices descend from it.

Decided
Jun 24, 2010
Review
108 days
Class
Class II
Product code
FMF
Recalls
None
Predicates
0

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

Descendants, by year cleared 2013: 1 descendant cleared2019: 2 descendants cleared2018: 1 descendant cleared2024: 1 descendant cleared2025: 1 descendant cleared2021: 2 descendants cleared2014: 1 descendant cleared2015: 1 descendant cleared2026: 1 descendant cleared2023: 1 descendant cleared2020: 1 descendant cleared2010201520202025
  1. This deviceK100665 Marromax B One Marrow Aspiration Needle Kit, Models 50083-XX, 50084-XXNeedle Tech Products, Inc. · 2010
  2. Descendant · cites it directly · 12 of its ownK131157 Ranfac Bone Marrow Aspiration NeedleRanfac, Corp. · 2013
  3. Descendant · 2 generations on · 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 · 2 generations on · 1 of its ownK240664 ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC · 2024
  6. Descendant · 3 generations on · 1 of its ownK223612 Ranfac Lateral Access Bone Marrow Aspiration Needle (CRVS-BMA-LA)Ranfac Corporation · 2023

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

2013: 12014: 12015: 12018: 12019: 22020: 12021: 22023: 12024: 12025: 12026: 1
2013high 2 (2019) · low 0 (2016)2026

Most influential descendants

Showing 5 of 13 · See all
  • K131157Ranfac Bone Marrow Aspiration NeedleRanfac, Corp. · 2013 · cites it directly12descendants
  • K140991Ranfac Aspiration Needle with Adjustable GuideRanfac, Corp. · 2014 · 2 generations on5descendants
  • K150563Marrow Cellution Bone Marrow Aspiration NeedleRanfac, Corp. · 2015 · 2 generations on4descendants
  • K240664ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC · 2024 · 2 generations on1descendant
  • K223612Ranfac Lateral Access Bone Marrow Aspiration Needle (CRVS-BMA-LA)Ranfac Corporation · 2023 · 3 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K100665Marromax B One Marrow Aspiration Needle Kit, Models 50083-XX, 50084-XXNeedle Tech Products, Inc.2010—
+1K131157Ranfac Bone Marrow Aspiration NeedleRanfac, Corp.2013—
+2K140991Ranfac Aspiration Needle with Adjustable GuideRanfac, Corp.2014—
+2K150563Marrow Cellution Bone Marrow Aspiration NeedleRanfac, Corp.2015—
+2K240664ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)SurGenTec, LLC2024—
+3K223612Ranfac Lateral Access Bone Marrow Aspiration Needle (CRVS-BMA-LA)Ranfac Corporation2023—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
201410
201510
201810
201920
202010
202120
202310
202410
202510
202610
FIG. 1 — Lineage of K100665, 2010–2026Source: 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 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in FMF? 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 FMF device

  1. #1 K241821 Luer Lock Syringe with Safety Needle; Luer…score 16.1 · 8 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’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (13)

See all 13

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

NumberDeviceApplicantDecidedDescendants
K131157Ranfac Bone Marrow Aspiration NeedleRanfac, Corp.201312

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, K131157 (Ranfac, Corp., 2013) has gone furthest, with 12 descendants of its own.

How does its category compare?

All FMF devices

FMF Syringe, Piston: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · FMF

13in 2025

2007: 232008: 92009: 142010: 112011: 162012: 92013: 122014: 132015: 112016: 122017: 132018: 82019: 112020: 152021: 202022: 242023: 222024: 142025: 132026 (partial year): 9
2007high 24 (2022) · low 8 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FMF

114in 2025

2007: 90 days median2008: 74 days median2009: 94 days median2010: 130 days median2011: 109 days median2012: 86 days median2013: 154 days median2014: 84 days median2015: 87 days median2016: 146 days median2017: 135 days median2018: 87 days median2019: 146 days median2020: 107 days median2021: 175 days median2022: 211 days median2023: 173 days median2024: 130 days median2025: 114 days median2026 (partial year): 239 days median
2007high 239 (2026) · low 74 (2008)2026

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

Recalls per year · FMF

19in 2023

2007: 62008: 112009: 152010: 122011: 32012: 62013: 12014: 12015: 22017: 32018: 22019: 12020: 22021: 12022: 22023: 19, 18 Class I2026 (partial year): 2, 1 Class I
2007high 19 (2023) · low 0 (2016)2026

Class I (19 since 2007) Class II/III not classified

Adverse event reports per year · FMF

4,181in 2025

2007: 6742008: 6912009: 9132010: 6792011: 1862012: 3072013: 3262014: 2442015: 2732016: 6842017: 1,8582018: 3,9522019: 5,8632020: 5,3342021: 5,8742022: 5,2332023: 5,2142024: 5,1222025: 4,181
2007high 5,874 (2021) · low 186 (2011)2025

MAUDE reports naming product code FMF, 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
200723906674
200897411691
2009149415913
20101113012679
2011161093186
20129866307
2013121541326
201413841244
201511872273
2016121460684
20171313531,858
201888723,952
20191114615,863
20201510725,334
20212017515,874
20222421125,233
20232217319 (18)5,214
20241413005,122
20251311404,181
202692392 (1)—

What is it indicated for?

The MARLROWMAX Bone Marrow Aspiration Needle is a stylet/cannula system to be used to obtain bone marrow and/or autologous blood from patients intraoperatively by use of a syringe.

Indications for use as stated in the FDA 510(k) statement.

More from Needle Tech Products, Inc.

3 FDA decisions under this applicant name. See the company

  • K143252Galt Tork, 0.010 to 0.020 inches (yellow), Galt Tork, 0.025 to 0.040 inches (orange)Needle Tech Products, Inc. · 2015
  • K031173Needletech Guidewire Introducer Needle, Models 40021, 40069, 40053, 40042 & 40013Needle Tech Products, Inc. · 2003

Recent decisions in FMF

The FMF category page

  • K262581GraftGun Universal Graft Delivery System (GDS®)SurGenTec, LLC · 2026
  • K252184SOL-M Luer Lock Syringe with Exchangeable Needle TraySol-Millennium Medical, Inc. · 2026
  • K253747Disposable Pen Injector (KXYC-03C02, KXYC-03A03)Jiangsu Enjosim Medical Technology Co., Ltd. · 2026
  • K260208Ultra-Fine™ SAFETY Insulin Syringeembecta Medical II, LLC · 2026
  • K253110Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeSol-Millennium Medical, Inc. · 2026

https://510kreport.com/device/K100665 · printed Nov 6, 2026

Cite this page

510(k) Report. “K100665: Marromax B One Marrow Aspiration Needle Kit, Models 50083-XX, 50084-XX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100665

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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