510(k) · Cleared

Cleared

Manan Prostatic Biopsy Needle

K895897510(k) TraditionalCleared Oct 18, 198912-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. · FCG Biopsy Needle

Cleared on Oct 18, 1989 after a 12-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 26 later devices descend from it.

Decided: Oct 18, 1989
Review: 12 days
Class: Class II
Product code: FCG
Recalls: None
Predicates: 0

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

This deviceK895897 Manan Prostatic Biopsy NeedleManan Medical Products, Inc. · 1989
Descendant · cites it directly · 22 of its ownK980226 Manan Pro-Mag Automatic Biopsy SystemMedical Device Technologies, Inc. · 1998 · Recalled
Descendant · 2 generations on · 18 of its ownK051506 Mielo-Can, Best-Lisas, Ben - Bone Biopsy. Fast-Cut, Colt…Sterylab S.R.L. · 2005
Descendant · 3 generations on · 12 of its ownK131157 Ranfac Bone Marrow Aspiration NeedleRanfac, Corp. · 2013
Descendant · 4 generations on · 5 of its ownK140991 Ranfac Aspiration Needle with Adjustable GuideRanfac, Corp. · 2014
Descendant · 4 generations on · 4 of its ownK150563 Marrow Cellution Bone Marrow Aspiration NeedleRanfac, Corp. · 2015

Showing 5 of 26 descendants. See all descendants

Descendants cleared per year

1998high 3 (2023) · low 0 (1999)2026

Most influential descendants

Showing 5 of 26 · See all

K980226Manan Pro-Mag Automatic Biopsy SystemMedical Device Technologies, Inc. · 1998 · cites it directly22descendants
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
K140991Ranfac Aspiration Needle with Adjustable GuideRanfac, Corp. · 2014 · 4 generations on5descendants
K150563Marrow Cellution Bone Marrow Aspiration NeedleRanfac, Corp. · 2015 · 4 generations on4descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K895897	Manan Prostatic Biopsy Needle	Manan Medical Products, Inc.	1989	—
+1	K980226	Manan Pro-Mag Automatic Biopsy System	Medical Device Technologies, Inc.	1998	1
+2	K051506	Mielo-Can, Best-Lisas, Ben - Bone Biopsy. Fast-Cut, Colt, Spring-Cut, Bio-Cut…	Sterylab S.R.L.	2005	—
+3	K131157	Ranfac Bone Marrow Aspiration Needle	Ranfac, Corp.	2013	—
+4	K140991	Ranfac Aspiration Needle with Adjustable Guide	Ranfac, Corp.	2014	—
+4	K150563	Marrow Cellution Bone Marrow Aspiration Needle	Ranfac, Corp.	2015	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	2	0
2002	1	0
2005	2	0
2007	2	0
2013	1	0
2014	2	0
2015	1	0
2017	1	0
2018	1	0
2019	2	0
2020	1	0
2021	2	0
2022	1	0
2023	3	0
2024	1	0
2025	2	0
2026	1	0

FIG. 1 — Lineage of K895897, 1989–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 FCG? 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 FCG device

#1 K250994 ClearTip FNA and FNB Typesscore 13.2 · 12 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin 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? (26)

See all 26

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

Number	Device	Applicant	Decided	Descendants
K980226	Manan Pro-Mag Automatic Biopsy System	Medical Device Technologies, Inc.	1998	22
K981166	Accucore Core Biopsy Needle Catalog Codes:581014, 581614, 581618, 582018, 582518…	Inrad	1998	2

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, K980226 (Medical Device Technologies, Inc., 1998) has gone furthest, with 22 descendants of its own.

How does its category compare?

All FCG devices

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

FDA decisions per year · FCG

2in 2025

2007high 6 (2018) · low 0 (2012)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FCG

82in 2023

2007high 166 (2017) · low 18 (2010)2026

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

Recalls per year · FCG

5in 2021

2007high 19 (2008) · low 0 (2007)2026

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

Adverse event reports per year · FCG

632in 2025

2007high 632 (2025) · low 11 (2007)2025

MAUDE reports naming product code FCG, 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	4	32	0	11
2008	1	—	19	115
2009	4	87	5	270
2010	3	18	4	73
2011	1	—	2	71
2012	0	—	0	107
2013	1	—	0	130
2014	5	88	0	154
2015	4	91	0	124
2016	3	63	0	191
2017	3	166	0	273
2018	6	140	0	282
2019	0	—	0	229
2020	1	—	0	240
2021	1	—	5	290
2022	2	—	0	302
2023	4	82	0	428
2024	1	—	0	446
2025	2	—	0	632
2026	0	—	0	—

https://510kreport.com/device/K895897 · printed Nov 6, 2026

Cite this page

510(k) Report. “K895897: Manan Prostatic 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/K895897

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026