510(k) · Cleared

Recalled · Class II · 2021

Manan (TM) Super-Core Biopsy Needles

K974814510(k) TraditionalCleared Jan 9, 199817-day reviewClass II21 CFR 876.1075Recalls 1

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

Medical Device Technologies, Inc. · KNW Instrument, Biopsy

Cleared on Jan 9, 1998 as substantially equivalent to K950732 (Manan Medical Products, Inc., 1995) after a 17-day review. Its family tree reaches back 1 generation to 1995. 30 later devices descend from it. It has been recalled once.

Decided: Jan 9, 1998
Review: 17 days
Class: Class II
Product code: KNW
Recalls: 1
Predicates: 1

Its longest line of descent runs back 1 generation to K950732 (1995). 30 later devices descend from it, 5 citing it directly.

By dateBy generation

Root · 1 generation backK950732 Manan Super-Core Biopsy NeedleManan Medical Products, Inc. · 1995
This deviceK974814 Manan (TM) Super-Core Biopsy NeedlesMedical Device Technologies, Inc. · 1998
Descendant · cites it directly · 18 of its ownK051506 Mielo-Can, Best-Lisas, Ben - Bone Biopsy. Fast-Cut, Colt…Sterylab S.R.L. · 2005
Descendant · 2 generations on · 12 of its ownK131157 Ranfac Bone Marrow Aspiration NeedleRanfac, Corp. · 2013
Descendant · cites it directly · 6 of its ownK161409 M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial…Mermaid Medical A/S · 2016
Descendant · 2 generations on · 5 of its ownK171953 Bard Mission Disposable Core Biopsy InstrumentBard Peripheral Vascular, Inc. · 2017 · Recalled
Descendant · 3 generations on · 5 of its ownK140991 Ranfac Aspiration Needle with Adjustable GuideRanfac, Corp. · 2014

Showing 5 of 30 descendants. See all descendants

Descendants cleared per year

2005high 3 (2005) · low 0 (2006)2026

Most influential descendants

Showing 5 of 30 · See all

K051506Mielo-Can, Best-Lisas, Ben - Bone Biopsy. Fast-Cut, Colt, Spring-Cut, Bio-Cut - Soft…Sterylab S.R.L. · 2005 · cites it directly18descendants
K131157Ranfac Bone Marrow Aspiration NeedleRanfac, Corp. · 2013 · 2 generations on12descendants
K161409M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle for SemMermaid Medical A/S · 2016 · cites it directly6descendants
K171953Bard Mission Disposable Core Biopsy InstrumentBard Peripheral Vascular, Inc. · 2017 · 2 generations on5descendants
K140991Ranfac Aspiration Needle with Adjustable GuideRanfac, Corp. · 2014 · 3 generations on5descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K950732	Manan Super-Core Biopsy Needle	Manan Medical Products, Inc.	1995	—
0 (this device)	K974814	Manan (TM) Super-Core Biopsy Needles	Medical Device Technologies, Inc.	1998	—
+1	K051506	Mielo-Can, Best-Lisas, Ben - Bone Biopsy. Fast-Cut, Colt, Spring-Cut, Bio-Cut…	Sterylab S.R.L.	2005	—
+2	K131157	Ranfac Bone Marrow Aspiration Needle	Ranfac, Corp.	2013	—
+1	K161409	M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle…	Mermaid Medical A/S	2016	—
+2	K171953	Bard Mission Disposable Core Biopsy Instrument	Bard Peripheral Vascular, Inc.	2017	3
+3	K140991	Ranfac Aspiration Needle with Adjustable Guide	Ranfac, Corp.	2014	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	3	0
2007	2	0
2008	1	0
2013	1	0
2014	2	0
2015	1	0
2016	1	0
2017	1	0
2018	1	0
2019	2	0
2020	2	0
2021	2	0
2022	2	0
2023	3	0
2024	2	0
2025	3	0
2026	1	0

FIG. 1 — Lineage of K974814, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), 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 K260572 Marrow Marxmanscore 14.5 · 10 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K950732	Manan Super-Core Biopsy Needle Summary page 1 …dle, biopsy (Manual surgical instrument for general use) SUBSTANTIAL EQUIVALENCE: Company Name Product Name 510(k) No. Manan Medical Products Super-Core Biopsy Needle K950732 DESCRIPTION OF DEVICE: The Manan™ Super-Core Biopsy Needle is used for obtaining soft tissue biopsies such as from the liver, ki…	Manan Medical Products, Inc.	1995	—

Also cleared against K950732: 1 other device →

What descends from it? (30)

See all 30

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

Number	Device	Applicant	Decided	Descendants
K051506	Mielo-Can, Best-Lisas, Ben - Bone Biopsy. Fast-Cut, Colt, Spring-Cut, Bio-Cut - Soft…	Sterylab S.R.L.	2005	18
K161409	M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle for Sem	Mermaid Medical A/S	2016	6
K052802	Manan Bio-Cut Soft Tissue Biopsy Needle	Manan Medical Products, Inc.	2005	1
K213232	NovaCore Semi-Automatic Biopsy Instrument	Argon Medical Devices	2022	0
K052435	Pneumrx Family of Biopsy Needles and Kits	Pneumrx, Inc.	2005	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Oct 4, 2021	Class II	Z-0354-2022	Device Design	Due to component (housing and plunger) detaching from the semi-automatic biopsy instruments.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K051506 (Sterylab S.R.L., 2005) has gone furthest, with 18 descendants of its own.
1 other device also cites its predicate K950732.

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

2007high 12 (2025) · low 3 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KNW

178in 2025

2007high 203 (2022) · low 35 (2009)2026

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

Recalls per year · KNW

1in 2024

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	6	94	1	766
2008	4	53	7	363
2009	6	35	3	351
2010	3	57	2	162
2011	10	64	5	67
2012	7	94	1	93
2013	3	100	1 (1)	98
2014	8	95	3	193
2015	10	106	0	591
2016	9	127	5	297
2017	8	90	1	760
2018	7	71	0	1,012
2019	5	94	4	4,195
2020	8	92	0	5,120
2021	9	54	3	1,020
2022	8	203	3	535
2023	7	164	2	931
2024	5	114	1	1,283
2025	12	178	0	1,667
2026	7	29	4 (3)	—

What is it indicated for?

The Manan™ Super-Core Biopsy Needle is used for obtaining soft tissue biopsies such as from the liver, kidney, prostate, breast, thyroid, pancreas, spleen, and lung.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K974814 · printed Nov 4, 2026

Cite this page

510(k) Report. “K974814: Manan (TM) Super-Core Biopsy Needles.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K974814

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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