510(k) Report

510(k) · Cleared

Cleared

Manan Super-Core Biopsy Needle

K950732510(k) TraditionalCleared Mar 2, 199514-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

Manan Medical Products, Inc. · KNW Instrument, Biopsy

Cleared on Mar 2, 1995 after a 14-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 31 later devices descend from it.

Decided
Mar 2, 1995
Review
14 days
Class
Class II
Product code
KNW
Recalls
None
Predicates
0

31 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 1998: 1 descendant cleared2005: 3 descendants cleared2008: 1 descendant cleared2016: 1 descendant cleared2022: 2 descendants cleared2013: 1 descendant cleared2007: 2 descendants cleared2017: 1 descendant cleared2014: 2 descendants cleared2019: 2 descendants cleared2018: 1 descendant cleared2024: 2 descendants cleared2025: 3 descendants cleared2021: 2 descendants cleared2015: 1 descendant cleared2026: 1 descendant cleared2023: 3 descendants cleared2020: 2 descendants cleared1995200020052010201520202025
  1. This deviceK950732 Manan Super-Core Biopsy NeedleManan Medical Products, Inc. · 1995
  2. Descendant · cites it directly · 30 of its ownK974814 Manan (TM) Super-Core Biopsy NeedlesMedical Device Technologies, Inc. · 1998 · Recalled
  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 · 3 generations on · 12 of its ownK131157 Ranfac Bone Marrow Aspiration NeedleRanfac, Corp. · 2013
  5. Descendant · 2 generations on · 6 of its ownK161409 M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial…Mermaid Medical A/S · 2016
  6. Descendant · 3 generations on · 5 of its ownK171953 Bard Mission Disposable Core Biopsy InstrumentBard Peripheral Vascular, Inc. · 2017 · Recalled

Showing 5 of 31 descendants. See all descendants

Descendants cleared per year

1998: 12005: 32007: 22008: 12013: 12014: 22015: 12016: 12017: 12018: 12019: 22020: 22021: 22022: 22023: 32024: 22025: 32026: 1
1998high 3 (2005) · low 0 (1999)2026

Most influential descendants

Showing 5 of 31 · See all
  • K974814Manan (TM) Super-Core Biopsy NeedlesMedical Device Technologies, Inc. · 1998 · cites it directly30descendants
  • K051506Mielo-Can, Best-Lisas, Ben - Bone Biopsy. Fast-Cut, Colt, Spring-Cut, Bio-Cut - Soft…Sterylab S.R.L. · 2005 · 2 generations on18descendants
  • K131157Ranfac Bone Marrow Aspiration NeedleRanfac, Corp. · 2013 · 3 generations on12descendants
  • K161409M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle for SemMermaid Medical A/S · 2016 · 2 generations on6descendants
  • K171953Bard Mission Disposable Core Biopsy InstrumentBard Peripheral Vascular, Inc. · 2017 · 3 generations on5descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K950732Manan Super-Core Biopsy NeedleManan Medical Products, Inc.1995—
+1K974814Manan (TM) Super-Core Biopsy NeedlesMedical Device Technologies, Inc.19981
+2K051506Mielo-Can, Best-Lisas, Ben - Bone Biopsy. Fast-Cut, Colt, Spring-Cut, Bio-Cut…Sterylab S.R.L.2005—
+3K131157Ranfac Bone Marrow Aspiration NeedleRanfac, Corp.2013—
+2K161409M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle…Mermaid Medical A/S2016—
+3K171953Bard Mission Disposable Core Biopsy InstrumentBard Peripheral Vascular, Inc.20173

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
200530
200720
200810
201310
201420
201510
201610
201710
201810
201920
202020
202120
202220
202330
202420
202530
202610
FIG. 1 — Lineage of K950732, 1995–2026Source: 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.

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?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (31)

See all 31

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

NumberDeviceApplicantDecidedDescendants
K974814Manan (TM) Super-Core Biopsy NeedlesMedical Device Technologies, Inc.199830
K052802Manan Bio-Cut Soft Tissue Biopsy NeedleManan Medical Products, Inc.20051

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, K974814 (Medical Device Technologies, Inc., 1998) has gone furthest, with 30 descendants of its own.

How does its category compare?

All KNW devices

KNW Instrument, Biopsy: FDA decisions, review times, recalls and adverse event reports over 20 years.

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)—

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 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/K950732 · printed Nov 6, 2026

Cite this page

510(k) Report. “K950732: Manan Super-Core Biopsy Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K950732

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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