510(k) Report

510(k) · Cleared

Cleared

Manan Pediatric Bone Marrow Access Needle

K962001510(k) TraditionalCleared Jan 10, 1997233-day reviewClass II21 CFR 880.5570

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

Manan Medical Products, Inc. · FMI Needle, Hypodermic, Single Lumen

Cleared on Jan 10, 1997 after a 233-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 of the 36 devices in its family, counting itself, has a Class I recall. 35 later devices descend from it.

Decided
Jan 10, 1997
Review
233 days
Class
Class II
Product code
FMI
Recalls
None
Predicates
0

35 later devices descend from it, 1 citing it directly. 1 of the 36 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 1998: 1 descendant cleared, 1 with a Class I recall12005: 3 descendants cleared2017: 2 descendants cleared2018: 1 descendant cleared2006: 1 descendant cleared2007: 4 descendants cleared2013: 1 descendant cleared2025: 3 descendants cleared2014: 2 descendants cleared2015: 3 descendants cleared2008: 1 descendant cleared2019: 2 descendants cleared2024: 1 descendant cleared2021: 3 descendants cleared2026: 1 descendant cleared2011: 1 descendant cleared2023: 2 descendants cleared2022: 1 descendant cleared2020: 1 descendant cleared2012: 1 descendant cleared1995200020052010201520202025
  1. This deviceK962001 Manan Pediatric Bone Marrow Access NeedleManan Medical Products, Inc. · 1997
  2. Descendant · cites it directly · 34 of its ownK980196 MD Tech Biopsy Set for Bone and Bone MarrowMedical Device Technologies, Inc. · 1998 · Recalled (Class I)
  3. Descendant · 2 generations on · 18 of its ownK051506 Mielo-Can, Best-Lisas, Ben - Bone Biopsy. Fast-Cut, Colt…Sterylab S.R.L. · 2005
  4. Descendant · 2 generations on · 14 of its ownK062833 Powered EZ-IO Bone Marrow Aspiration SystemVidacare Corporation · 2006
  5. Descendant · 2 generations on · 14 of its ownK043523 Interv Brand Snarelok Bone Marrow Biopsy NeedleMedical Device Technologies, Inc. · 2005
  6. Descendant · 3 generations on · 12 of its ownK131157 Ranfac Bone Marrow Aspiration NeedleRanfac, Corp. · 2013

Showing 5 of 35 descendants. See all descendants

Descendants cleared per year

1998: 12005: 32006: 12007: 42008: 12011: 12012: 12013: 12014: 22015: 32017: 22018: 12019: 22020: 12021: 32022: 12023: 22024: 12025: 32026: 1
1998high 4 (2007) · low 0 (1999)2026

Class I recalls in this family

  • K980196 MD Tech Biopsy Set for Bone and Bone Marrowcites it directly · 1998

Most influential descendants

Showing 5 of 35 · See all
  • K980196MD Tech Biopsy Set for Bone and Bone MarrowMedical Device Technologies, Inc. · 1998 · cites it directly34descendants
  • K051506Mielo-Can, Best-Lisas, Ben - Bone Biopsy. Fast-Cut, Colt, Spring-Cut, Bio-Cut - Soft…Sterylab S.R.L. · 2005 · 2 generations on18descendants
  • K062833Powered EZ-IO Bone Marrow Aspiration SystemVidacare Corporation · 2006 · 2 generations on14descendants
  • K043523Interv Brand Snarelok Bone Marrow Biopsy NeedleMedical Device Technologies, Inc. · 2005 · 2 generations on14descendants
  • K131157Ranfac Bone Marrow Aspiration NeedleRanfac, Corp. · 2013 · 3 generations on12descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K962001Manan Pediatric Bone Marrow Access NeedleManan Medical Products, Inc.1997—
+1K980196MD Tech Biopsy Set for Bone and Bone MarrowMedical Device Technologies, Inc.1998Class I
+2K051506Mielo-Can, Best-Lisas, Ben - Bone Biopsy. Fast-Cut, Colt, Spring-Cut, Bio-Cut…Sterylab S.R.L.2005—
+2K062833Powered EZ-IO Bone Marrow Aspiration SystemVidacare Corporation2006—
+2K043523Interv Brand Snarelok Bone Marrow Biopsy NeedleMedical Device Technologies, Inc.2005—
+3K131157Ranfac Bone Marrow Aspiration NeedleRanfac, Corp.2013—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199811
200530
200610
200740
200810
201110
201210
201310
201420
201530
201720
201810
201920
202010
202130
202210
202320
202410
202530
202610
FIG. 1 — Lineage of K962001, 1997–2026Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

1 device in this family has a Class I recall. 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 FMI device

  1. #1 K252886 Pen Needlescore 14.5 · 4 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (35)

See all 35

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

NumberDeviceApplicantDecidedDescendants
K980196MD Tech Biopsy Set for Bone and Bone Marrow Class IMedical Device Technologies, Inc.199834

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K980196MD Tech Biopsy Set for Bone and Bone MarrowMedical Device Technologies, Inc. · 1998 · Cites it directly · ◆ in the 1998 descendants bar of FIG. 13 Class I recalls

What does this lineage say?

  • Of its descendants, K980196 (Medical Device Technologies, Inc., 1998) has gone furthest, with 34 descendants of its own.

How does its category compare?

All FMI devices

FMI Needle, Hypodermic, Single Lumen: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FMI

11in 2025

2007: 152008: 102009: 72010: 152011: 122012: 172013: 112014: 142015: 102016: 202017: 92018: 202019: 122020: 112021: 182022: 232023: 182024: 32025: 112026 (partial year): 12
2007high 23 (2022) · low 3 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FMI

141in 2025

2007: 71 days median2008: 85 days median2009: 177 days median2010: 119 days median2011: 113 days median2012: 107 days median2013: 87 days median2014: 155 days median2015: 89 days median2016: 217 days median2017: 253 days median2018: 176 days median2019: 186 days median2020: 263 days median2021: 143 days median2022: 189 days median2023: 112 days median2024: 90 days median2025: 141 days median2026 (partial year): 119 days median
2007high 263 (2020) · low 71 (2007)2026

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

Recalls per year · FMI

1in 2024

2007: 22008: 42009: 32010: 792011: 52012: 12013: 12014: 32015: 12017: 162019: 52020: 32021: 72023: 22024: 12026 (partial year): 1, 1 Class I
2007high 79 (2010) · low 0 (2016)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · FMI

2,424in 2025

2007: 2082008: 1772009: 2632010: 2492011: 2402012: 2152013: 2552014: 2872015: 5672016: 9412017: 1,5472018: 2,3982019: 4,8962020: 4,2452021: 4,5322022: 4,8852023: 4,9862024: 4,0532025: 2,424
2007high 4,986 (2023) · low 177 (2008)2025

MAUDE reports naming product code FMI, 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
200715712208
200810854177
200971773263
20101511979249
2011121135240
2012171071215
201311871255
2014141553287
201510891567
2016202170941
20179253161,547
20182017602,398
20191218654,896
20201126334,245
20211814374,532
20222318904,885
20231811224,986
202439014,053
20251114102,424
2026121191 (1)—

More from Manan Medical Products, Inc.

39 FDA decisions under this applicant name. See the company

  • K052802Manan Bio-Cut Soft Tissue Biopsy NeedleManan Medical Products, Inc. · 2005
  • K011209Manan Spritacre Spinal NeedlesManan Medical Products, Inc. · 2001
  • K983620Manan Spinal NeedlesManan Medical Products, Inc. · 1999
  • K980536Epidural NeedleManan Medical Products, Inc. · 1998
  • K981386Manan Blunt NeedleManan Medical Products, Inc. · 1998

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The FMI category page

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https://510kreport.com/device/K962001 · printed Nov 5, 2026

Cite this page

510(k) Report. “K962001: Manan Pediatric Bone Marrow Access Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K962001

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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