510(k) Report

510(k) · Cleared

Cleared

Manan Bone Marrow Harvest Needles

K940025510(k) TraditionalCleared Feb 25, 199453-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. · GAA Needle, Aspiration And Injection, Disposable

Cleared on Feb 25, 1994 after a 53-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 43 devices in its family, counting itself, has a Class I recall. 42 later devices descend from it.

Decided
Feb 25, 1994
Review
53 days
Class
Class I
Product code
GAA
Recalls
None
Predicates
0

42 later devices descend from it, 2 citing it directly. 1 of the 43 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 2005: 4 descendants cleared1996: 1 descendant cleared2013: 1 descendant cleared2015: 5 descendants cleared2014: 4 descendants cleared1998: 1 descendant cleared, 1 with a Class I recall12019: 2 descendants cleared2018: 1 descendant cleared2024: 1 descendant cleared2025: 3 descendants cleared2021: 4 descendants cleared2026: 1 descendant cleared2017: 2 descendants cleared2006: 1 descendant cleared2007: 4 descendants cleared2023: 2 descendants cleared2020: 1 descendant cleared2008: 1 descendant cleared2011: 1 descendant cleared2022: 1 descendant cleared2012: 1 descendant cleared1990200020102020
  1. This deviceK940025 Manan Bone Marrow Harvest NeedlesManan Medical Products, Inc. · 1994
  2. Descendant · cites it directly · 35 of its ownK961959 MD Tech Biopsy Set for Bone and Bone MarrowMedical Device Technologies, Inc. · 1996
  3. Descendant · 2 generations on · 34 of its ownK980196 MD Tech Biopsy Set for Bone and Bone MarrowMedical Device Technologies, Inc. · 1998 · Recalled (Class I)
  4. Descendant · cites it directly · 19 of its ownK050795 Imbibe Bone Marrow Aspiration NeedleOrthovita, Inc. · 2005
  5. Descendant · 3 generations on · 18 of its ownK051506 Mielo-Can, Best-Lisas, Ben - Bone Biopsy. Fast-Cut, Colt…Sterylab S.R.L. · 2005
  6. Descendant · 3 generations on · 14 of its ownK062833 Powered EZ-IO Bone Marrow Aspiration SystemVidacare Corporation · 2006

Showing 5 of 42 descendants. See all descendants

Descendants cleared per year

1996: 11998: 12005: 42006: 12007: 42008: 12011: 12012: 12013: 12014: 42015: 52017: 22018: 12019: 22020: 12021: 42022: 12023: 22024: 12025: 32026: 1
1996high 5 (2015) · low 0 (1997)2026

Class I recalls in this family

  • K980196 MD Tech Biopsy Set for Bone and Bone Marrow2 generations on · 1998

Most influential descendants

Showing 5 of 42 · See all
  • K961959MD Tech Biopsy Set for Bone and Bone MarrowMedical Device Technologies, Inc. · 1996 · cites it directly35descendants
  • K980196MD Tech Biopsy Set for Bone and Bone MarrowMedical Device Technologies, Inc. · 1998 · 2 generations on34descendants
  • K050795Imbibe Bone Marrow Aspiration NeedleOrthovita, Inc. · 2005 · cites it directly19descendants
  • K051506Mielo-Can, Best-Lisas, Ben - Bone Biopsy. Fast-Cut, Colt, Spring-Cut, Bio-Cut - Soft…Sterylab S.R.L. · 2005 · 3 generations on18descendants
  • K062833Powered EZ-IO Bone Marrow Aspiration SystemVidacare Corporation · 2006 · 3 generations on14descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K940025Manan Bone Marrow Harvest NeedlesManan Medical Products, Inc.1994—
+1K961959MD Tech Biopsy Set for Bone and Bone MarrowMedical Device Technologies, Inc.1996—
+2K980196MD Tech Biopsy Set for Bone and Bone MarrowMedical Device Technologies, Inc.1998Class I
+1K050795Imbibe Bone Marrow Aspiration NeedleOrthovita, Inc.2005—
+3K051506Mielo-Can, Best-Lisas, Ben - Bone Biopsy. Fast-Cut, Colt, Spring-Cut, Bio-Cut…Sterylab S.R.L.2005—
+3K062833Powered EZ-IO Bone Marrow Aspiration SystemVidacare Corporation2006—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
199811
200540
200610
200740
200810
201110
201210
201310
201440
201550
201720
201810
201920
202010
202140
202210
202320
202410
202530
202610
FIG. 1 — Lineage of K940025, 1994–2026Source: 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 GAA device

  1. #1 K223625 CapnoSpot™ Pneumothorax Decompression Indicatorscore 5.1 · 1 generation · no Class I recall
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? (42)

See all 42

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K961959MD Tech Biopsy Set for Bone and Bone MarrowMedical Device Technologies, Inc.199635
K050795Imbibe Bone Marrow Aspiration NeedleOrthovita, Inc.200519

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 · 2 generations on · ◆ in the 1998 descendants bar of FIG. 13 Class I recalls

What does this lineage say?

  • Of its descendants, K961959 (Medical Device Technologies, Inc., 1996) has gone furthest, with 35 descendants of its own.

How does its category compare?

All GAA devices

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

FDA decisions per year · GAA

1in 2023

2011: 12023: 1
2007high 1 (2011) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GAA

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

Recalls per year · GAA

2in 2022

2008: 12009: 22010: 22019: 102021: 52022: 2
2007high 10 (2019) · low 0 (2007)2026

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

Adverse event reports per year · GAA

348in 2025

2007: 122008: 322009: 202010: 182011: 92012: 242013: 332014: 242015: 322016: 452017: 852018: 1222019: 1532020: 1022021: 1082022: 742023: 1182024: 1812025: 348
2007high 348 (2025) · low 9 (2011)2025

MAUDE reports naming product code GAA, 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
20070—012
20080—132
20090—220
20100—218
20111—09
20120—024
20130—033
20140—024
20150—032
20160—045
20170—085
20180—0122
20190—10153
20200—0102
20210—5108
20220—274
20231—0118
20240—0181
20250—0348
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 GAA

The GAA category page

  • K223625CapnoSpot™ Pneumothorax Decompression IndicatorPneumeric, Inc. · 2023
  • K102274Arvik Laparoscopic Aspiration InstrumentArvik Enterprises/ Mini Lap Technologies · 2011
  • K011586Irma SL Blood Analysis System GL CartridgeDiametrics Medical, Inc. · 2001
  • K994151Percutx-Injection/Aspiration Needle Probes/DevicesXimed/Prosure/Injectx · 2000
  • K983200Injection/Aspiration Needles Probes/Devices-Tpi/Tpi FlexXimed/Prosure/Injectx · 1998

https://510kreport.com/device/K940025 · printed Nov 6, 2026

Cite this page

510(k) Report. “K940025: Manan Bone Marrow Harvest Needles.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K940025

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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