510(k) Report

510(k) · Cleared

Cleared

Manan Chiba PTC Needle

K851838510(k) TraditionalCleared Jun 21, 198556-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 Manufacturing Co., Inc. · KNW Instrument, Biopsy

Cleared on Jun 21, 1985 after a 56-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 21 devices in its family, counting itself, has a Class I recall. 20 later devices descend from it.

Decided
Jun 21, 1985
Review
56 days
Class
Class II
Product code
KNW
Recalls
None
Predicates
0

20 later devices descend from it, 2 citing it directly. 1 of the 21 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 2002: 1 descendant cleared1998: 1 descendant cleared2005: 1 descendant cleared2014: 1 descendant cleared2015: 2 descendants cleared2017: 2 descendants cleared2004: 1 descendant cleared2007: 1 descendant cleared2016: 1 descendant cleared2021: 1 descendant cleared2018: 1 descendant cleared2025: 2 descendants cleared2008: 1 descendant cleared2020: 1 descendant cleared, 1 with a Class I recall12023: 1 descendant cleared2024: 1 descendant cleared2026: 1 descendant cleared1990200020102020
  1. This deviceK851838 Manan Chiba PTC NeedleManan Manufacturing Co., Inc. · 1985
  2. Descendant · cites it directly · 11 of its ownK021847 Biopsy Sciences, LLC. Maxi-Cell Biopsy NeedlesBiopsy Sciences, LLC · 2002
  3. Descendant · 2 generations on · 9 of its ownK142688 Echotip Procore HD Ultrasound Biopsy NeedleCook Ireland, Ltd. · 2014
  4. Descendant · cites it directly · 8 of its ownK980122 Manan Soft Tissue Biopsy NeedlesMedical Device Technologies, Inc. · 1998
  5. Descendant · 3 generations on · 7 of its ownK160229 Echotip Ultra Endobronchial High Definition Ultrasound Needle…Cook Ireland, Ltd. · 2016
  6. Descendant · 3 generations on · 2 of its ownK210476 EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD…Cook Ireland, Ltd. · 2021 · Recalled

Showing 5 of 20 descendants. See all descendants

Descendants cleared per year

1998: 12002: 12004: 12005: 12007: 12008: 12014: 12015: 22016: 12017: 22018: 12020: 12021: 12023: 12024: 12025: 22026: 1
1998high 2 (2015) · low 0 (1999)2026

Class I recalls in this family

  • K193517 ViziShot 2 FLEX4 generations on · 2020

Most influential descendants

Showing 5 of 20 · See all
  • K021847Biopsy Sciences, LLC. Maxi-Cell Biopsy NeedlesBiopsy Sciences, LLC · 2002 · cites it directly11descendants
  • K142688Echotip Procore HD Ultrasound Biopsy NeedleCook Ireland, Ltd. · 2014 · 2 generations on9descendants
  • K980122Manan Soft Tissue Biopsy NeedlesMedical Device Technologies, Inc. · 1998 · cites it directly8descendants
  • K160229Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore…Cook Ireland, Ltd. · 2016 · 3 generations on7descendants
  • K210476EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound Biopsy Needle…Cook Ireland, Ltd. · 2021 · 3 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K851838Manan Chiba PTC NeedleManan Manufacturing Co., Inc.1985—
+1K021847Biopsy Sciences, LLC. Maxi-Cell Biopsy NeedlesBiopsy Sciences, LLC2002—
+2K142688Echotip Procore HD Ultrasound Biopsy NeedleCook Ireland, Ltd.2014—
+1K980122Manan Soft Tissue Biopsy NeedlesMedical Device Technologies, Inc.1998—
+3K160229Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore…Cook Ireland, Ltd.2016—
+3K210476EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound…Cook Ireland, Ltd.20211

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
200210
200410
200510
200710
200810
201410
201520
201610
201720
201810
202011
202110
202310
202410
202520
202610
FIG. 1 — Lineage of K851838, 1985–2026Source: 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 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 has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (20)

See all 20

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

NumberDeviceApplicantDecidedDescendants
K021847Biopsy Sciences, LLC. Maxi-Cell Biopsy NeedlesBiopsy Sciences, LLC200211
K980122Manan Soft Tissue Biopsy NeedlesMedical Device Technologies, Inc.19988

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.

  • K193517ViziShot 2 FLEXOlympus Surgical Technologies America · 2020 · 4 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Of its descendants, K021847 (Biopsy Sciences, LLC, 2002) has gone furthest, with 11 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 Manufacturing Co., Inc.

20 FDA decisions under this applicant name. See the company

  • K873208Manan Turner Style NeedleManan Manufacturing Co., Inc. · 1987
  • K864405Manan Contrast Media Administration SetManan Manufacturing Co., Inc. · 1986
  • K863848Manan Brest Tumor Localization NeedleManan Manufacturing Co., Inc. · 1986
  • K851833Manan Seldinger NeedleManan Manufacturing Co., Inc. · 1985
  • K852501Myelogram Procedure TrayManan Manufacturing Co., Inc. · 1985

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/K851838 · printed Nov 5, 2026

Cite this page

510(k) Report. “K851838: Manan Chiba PTC Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K851838

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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