510(k) Report

510(k) · Cleared

Cleared

Manan Bone Biopsy Needle

K902177510(k) TraditionalCleared Sep 5, 1990113-day reviewClass I21 CFR 878.4800

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. · GDM Needle, Aspiration And Injection, Reusable

Cleared on Sep 5, 1990 after a 113-day review. FDA has not posted a summary or statement for it, 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
Sep 5, 1990
Review
113 days
Class
Class I
Product code
GDM
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 cleared1990200020102020
  1. This deviceK902177 Manan Bone Biopsy NeedleManan Medical Products, Inc. · 1990
  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)K902177Manan Bone Biopsy NeedleManan Medical Products, Inc.1990—
+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 K902177, 1990–2026Source: 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.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin 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? (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 GDM devices

GDM Needle, Aspiration And Injection, Reusable: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GDM

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GDM

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

Recalls per year · GDM

2in 2009

2009: 2
2007high 2 (2009) · low 0 (2007)2026

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

Adverse event reports per year · GDM

5in 2025

2009: 22013: 32014: 82015: 22016: 12017: 22018: 42020: 22021: 22022: 32023: 32024: 52025: 5
2007high 8 (2014) · low 0 (2007)2025

MAUDE reports naming product code GDM, 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
20071—00
20080—00
20090—22
20100—00
20110—00
20120—00
20130—03
20140—08
20150—02
20160—01
20170—02
20180—04
20190—00
20200—02
20210—02
20220—03
20230—03
20240—05
20250—05
20260—0—

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

Recent decisions in GDM

The GDM category page

  • K071732MarrowminerStemcor Systems, Inc. · 2007
  • K971114Bioaccess Marrow Harvest SystemBioaccess, Inc. · 1997
  • K953082Iliac Crest Bone Marrow Aspiration NeedleBaxter Healthcare Corp · 1995
  • K953064Bioaccess Marrow Harvest SystemBioaccess, Inc. · 1995
  • K936207Endo-Needle InstrumentGerard Medical, Inc. · 1994

https://510kreport.com/device/K902177 · printed Nov 5, 2026

Cite this page

510(k) Report. “K902177: Manan Bone Biopsy Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K902177

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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