510(k) Report

510(k) · Cleared

Cleared

Manan Soft Tissue Biopsy Needles

K980122510(k) TraditionalCleared Jan 30, 199816-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

Medical Device Technologies, Inc. · KNW Instrument, Biopsy

Cleared on Jan 30, 1998 as substantially equivalent to K944837 (Medical Device Technologies, Inc., 1994) and 7 other predicates after a 16-day review. Its family tree reaches back 1 generation to 1985. 8 later devices descend from it.

Decided
Jan 30, 1998
Review
16 days
Class
Class II
Product code
KNW
Recalls
None
Predicates
8

Its longest line of descent runs back 1 generation to K851831 (1985). 8 ancestors in all. 8 later devices descend from it, 5 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1994: 1 other ancestor1987: 1 other ancestor1985: 5 other ancestors2015: 2 descendants cleared2017: 1 descendant cleared2005: 1 descendant cleared2004: 1 descendant cleared2007: 1 descendant cleared2025: 1 descendant cleared2008: 1 descendant clearedK851831 · Manan Franseene Needle · Manan Manufacturing Co., Inc. · 19851990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 7 other ancestors 1 generation forward: 5 descendants2 generations forward: 2 descendants3 generations forward: 1 descendant K851831 · Manan Franseene Needle · Manan Manufacturing Co., Inc. · 19850
  1. Root · 1 generation backK851831 Manan Franseene NeedleManan Manufacturing Co., Inc. · 1985
  2. This deviceK980122 Manan Soft Tissue Biopsy NeedlesMedical Device Technologies, Inc. · 1998
  3. Descendant · cites it directly · 2 of its ownK041638 Targetscan Biopsy KitEnvisioneering, LLC · 2004
  4. Descendant · cites it directly · 1 of its ownK162588 Möller Medical Biopsy Needles and SystemsMoller Medical GmbH · 2017
  5. Descendant · 2 generations on · 1 of its ownK073399 Targetscan Biopsy Kit, Targetscan Biopsy Needle GuideEnvisioneering, LLC · 2007
  6. Descendant · 2 generations on · 0 of its ownK242128 Forsvall biopsy needle system for prostate biopsy (Forsvall biopsy…Xaga Surgical · 2025
  7. Descendant · cites it directly · 0 of its ownK150625 Morrison Steerable NeedleApriomed AB · 2015

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2004: 12005: 12007: 12008: 12015: 22017: 12025: 1
2004high 2 (2015) · low 0 (2006)2026

Most influential descendants

Showing 5 of 8 · See all
  • K041638Targetscan Biopsy KitEnvisioneering, LLC · 2004 · cites it directly2descendants
  • K162588Möller Medical Biopsy Needles and SystemsMoller Medical GmbH · 2017 · cites it directly1descendant
  • K073399Targetscan Biopsy Kit, Targetscan Biopsy Needle GuideEnvisioneering, LLC · 2007 · 2 generations on1descendant
  • K242128Forsvall biopsy needle system for prostate biopsy (Forsvall biopsy gun and Forsvall…Xaga Surgical · 2025 · 2 generations on0descendants
  • K150625Morrison Steerable NeedleApriomed AB · 2015 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K851831Manan Franseene NeedleManan Manufacturing Co., Inc.1985—
0 (this device)K980122Manan Soft Tissue Biopsy NeedlesMedical Device Technologies, Inc.1998—
+1K041638Targetscan Biopsy KitEnvisioneering, LLC2004—
+1K162588Möller Medical Biopsy Needles and SystemsMoller Medical GmbH2017—
+2K073399Targetscan Biopsy Kit, Targetscan Biopsy Needle GuideEnvisioneering, LLC2007—
+2K242128Forsvall biopsy needle system for prostate biopsy (Forsvall biopsy gun and…Xaga Surgical2025—
+1K150625Morrison Steerable NeedleApriomed AB2015—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198550
198710
199410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200510
200710
200810
201520
201710
202510
FIG. 1 — Lineage of K980122, 1985–2025Source: 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), 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. #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? (8)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K944837Medical Device Technologies Manual Biopsy Needle
Summary page 1
…N NAME: Needle, Biopsy, Cardiovascular, No. 79DWO SUBSTANTIAL EQUIVALENCE: Company Name Product Name S10(k} No, Medical Device Technologies, Inc. Manual Biopsy Needles K944837 Manan Medical Products Franseen Needle K851831 Manan Medical Products Greene Needle K851835 Manan Medical Products Westcott Needl…
Medical Device Technologies, Inc.1994—
*K851831Manan Franseene Needle
Summary page 1
…WO SUBSTANTIAL EQUIVALENCE: Company Name Product Name S10(k} No, Medical Device Technologies, Inc. Manual Biopsy Needles K944837 Manan Medical Products Franseen Needle K851831 Manan Medical Products Greene Needle K851835 Manan Medical Products Westcott Needle K851837 Manan Medical Products Chiba Needle K…
Manan Manufacturing Co., Inc.1985—
*K851835Manan Greene Needle
Summary page 1
…oduct Name S10(k} No, Medical Device Technologies, Inc. Manual Biopsy Needles K944837 Manan Medical Products Franseen Needle K851831 Manan Medical Products Greene Needle K851835 Manan Medical Products Westcott Needle K851837 Manan Medical Products Chiba Needle K851838 Manan Medical Products Trocar Needle K…
Manan Manufacturing Co., Inc.1985—
*K851837Manan Westcott Needle
Summary page 1
…es, Inc. Manual Biopsy Needles K944837 Manan Medical Products Franseen Needle K851831 Manan Medical Products Greene Needle K851835 Manan Medical Products Westcott Needle K851837 Manan Medical Products Chiba Needle K851838 Manan Medical Products Trocar Needle K852426 Manan Medical Products Spinal Needle K85…
Manan Manufacturing Co., Inc.1985—
*K851838Manan Chiba PTC Needle
Summary page 1
…Medical Products Franseen Needle K851831 Manan Medical Products Greene Needle K851835 Manan Medical Products Westcott Needle K851837 Manan Medical Products Chiba Needle K851838 Manan Medical Products Trocar Needle K852426 Manan Medical Products Spinal Needle K852427 Manan Medical Products Turner Needle K8…
Manan Manufacturing Co., Inc.1985—
*K852426Manan Trocar Style Biopsy Needle
Summary page 1
…an Medical Products Greene Needle K851835 Manan Medical Products Westcott Needle K851837 Manan Medical Products Chiba Needle K851838 Manan Medical Products Trocar Needle K852426 Manan Medical Products Spinal Needle K852427 Manan Medical Products Turner Needle K873208 DESCRIPTION OF DEVICE: These devices a…
Manan Manufacturing Co., Inc.1985—
*K852427Manan Spinal Needle
Summary page 1
…an Medical Products Westcott Needle K851837 Manan Medical Products Chiba Needle K851838 Manan Medical Products Trocar Needle K852426 Manan Medical Products Spinal Needle K852427 Manan Medical Products Turner Needle K873208 DESCRIPTION OF DEVICE: These devices are intended to be used in percutaneous soft t…
Manan Manufacturing Co., Inc.1985—
*K873208Manan Turner Style Needle
Summary page 1
…anan Medical Products Chiba Needle K851838 Manan Medical Products Trocar Needle K852426 Manan Medical Products Spinal Needle K852427 Manan Medical Products Turner Needle K873208 DESCRIPTION OF DEVICE: These devices are intended to be used in percutaneous soft tissue (pleura cavity and associated organs, a…
Manan Manufacturing Co., Inc.1987—

What descends from it? (8)

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

NumberDeviceApplicantDecidedDescendants
K041638Targetscan Biopsy KitEnvisioneering, LLC20042
K162588Möller Medical Biopsy Needles and SystemsMoller Medical GmbH20171
K150625Morrison Steerable NeedleApriomed AB20150
K142791Spectra Soft Tissue Biopsy NeedlesSpectra Medical Devices20150
K052435Pneumrx Family of Biopsy Needles and KitsPneumrx, Inc.20050

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?

  • None of the 8 ancestors has a recall.
  • Of its descendants, K041638 (Envisioneering, LLC, 2004) has gone furthest, with 2 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)—

What is it indicated for?

The Manan™ Soft Tissue Biopsy Needles are intended to be used in percutaneous soft tissue (pleura cavity and associated organs, abdominal cavity and associated organs, etc.) biopsies effected via the insertion of the device by a qualified physician, under guidance (CT, Ultrasound, Sequential Mammography, or Fluoroscopy), and manipulated in such a manner that a tissue specimen is retained within a collection orifice on the needle.

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

More from Medical Device Technologies, Inc.

46 FDA decisions under this applicant name. See the company

  • K101832Biopince Ultra Full Core Biopsy InstrumentMedical Device Technologies, Inc. · 2010
  • K053518Interv Brand V-Mark Breast Biopsy Site Marker with Titanium AnchorMedical Device Technologies, Inc. · 2006
  • K051421Inter V Brand V-Mark Breast Biopsy Site Marker with Titanium AnchorMedical Device Technologies, Inc. · 2005
  • K050873Canalizer Hydrophilic Guide WireMedical Device Technologies, Inc. · 2005
  • K043523Interv Brand Snarelok Bone Marrow Biopsy NeedleMedical Device Technologies, Inc. · 2005

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/K980122 · printed Nov 5, 2026

Cite this page

510(k) Report. “K980122: Manan Soft Tissue Biopsy Needles.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K980122

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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