510(k) Report

510(k) · Cleared

Cleared

Model 121 Biopsy Needle, Model 111 Biopsy Needle, Model 112 Biopsy Needle, and Model 131 Disposable Coaxial Biopsy Needle

K214063510(k) TraditionalCleared Jun 3, 2022158-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

Guangzhou Shengwei Medical Devices Co., Ltd. · KNW Instrument, Biopsy

Cleared on Jun 3, 2022 as substantially equivalent to K853312 (Argon Medical Corp., 1985) and 2 other predicates after a 158-day review. Its family tree reaches back 4 generations to 1993.

Decided
Jun 3, 2022
Review
158 days
Class
Class II
Product code
KNW
Recalls
None
Predicates
3

Its longest line of descent runs back 4 generations to K922939 (1993). 8 ancestors in all, the oldest K853312 (1985). No later device cites it as a predicate yet.

Other ancestors, by year cleared 1985: 1 other ancestor2000: 1 other ancestor1996: 1 other ancestor1994: 1 other ancestorK922939 · Bard Monopty Disposable Core Biopsy Isnt. W/ Cent. · C.R. Bard, Inc. · 1993K133948 · Bard (R) Monopty (R) Disposable Core Biopsy Instrument, Bard (R) Max-Core (R) Disposable Core Instrument · Bard Peripheral Vascular, Inc. · 2014 · recalledK141552 · Achieve Programmable Auomated Biopsy Systems · Care Fusion · 2014K160316 · SemiCut Semi-automatic Biopsy Needle, Themy Automatic Disposable Biopsy Device, Palium Automatic Reusable Biopsy Device, EasyCut Semi-automatic Biopsy Needle, MDL Biopsy and Coaxial Introducer Needles · M.D.L. S.R.L. · 2016 · recalled1990200020102020
Other ancestors, by generation 1 generation back: 1 other ancestor2 generations back: 3 other ancestors K160316 · SemiCut Semi-automatic Biopsy Needle, Themy Automatic Disposable Biopsy Device, Palium Automatic Reusable Biopsy Device, EasyCut Semi-automatic Biopsy Needle, MDL Biopsy and Coaxial Introducer Needles · M.D.L. S.R.L. · 2016 · recalledK141552 · Achieve Programmable Auomated Biopsy Systems · Care Fusion · 2014K133948 · Bard (R) Monopty (R) Disposable Core Biopsy Instrument, Bard (R) Max-Core (R) Disposable Core Instrument · Bard Peripheral Vascular, Inc. · 2014 · recalledK922939 · Bard Monopty Disposable Core Biopsy Isnt. W/ Cent. · C.R. Bard, Inc. · 19930
  1. Root · 4 generations backK922939 Bard Monopty Disposable Core Biopsy Isnt. W/ Cent.C.R. Bard, Inc. · 1993
  2. 3 generations backK133948 Bard (R) Monopty (R) Disposable Core Biopsy Instrument, Bard (R)…Bard Peripheral Vascular, Inc. · 2014 · Recalled
  3. 2 generations backK141552 Achieve Programmable Auomated Biopsy SystemsCare Fusion · 2014
  4. 1 generation backK160316 SemiCut Semi-automatic Biopsy Needle, Themy Automatic Disposable…M.D.L. S.R.L. · 2016 · Recalled
  5. This deviceK214063 Model 121 Biopsy Needle, Model 111 Biopsy Needle, Model 112 Biopsy…Guangzhou Shengwei Medical Devices Co., Ltd. · 2022
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K922939Bard Monopty Disposable Core Biopsy Isnt. W/ Cent.C.R. Bard, Inc.1993—
−3K133948Bard (R) Monopty (R) Disposable Core Biopsy Instrument, Bard (R) Max-Core (R)…Bard Peripheral Vascular, Inc.20147
−2K141552Achieve Programmable Auomated Biopsy SystemsCare Fusion2014—
−1K160316SemiCut Semi-automatic Biopsy Needle, Themy Automatic Disposable Biopsy…M.D.L. S.R.L.20161
0 (this device)K214063Model 121 Biopsy Needle, Model 111 Biopsy Needle, Model 112 Biopsy Needle, and…Guangzhou Shengwei Medical Devices Co., Ltd.2022—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198510
199410
199610
200010
FIG. 1 — Lineage of K214063, 1993–2022Source: 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
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What was it cleared against? (3)

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
*K853312Argon Cut Biopsy Needles, Various Sizes
Summary page 4
…Biopsy Needle Regulation number 21 CFR 876.1075 Regulation Class: Class II Product Code: KNW FCG 3. PREDICATE DEVICE K853312 ARGON CUT BIOPSY NEEDLES, VARIOUS SIZES K133948 BARD(R) MAX‐CORE(R) DISPOSABLE CORE INSTRUMENT K160316, Biopsy Devices and Acce…
Argon Medical Corp.1985—
*K133948Bard (R) Monopty (R) Disposable Core Biopsy Instrument, Bard (R) Max-Core (R) Disposable…
Summary page 4
…21 CFR 876.1075 Regulation Class: Class II Product Code: KNW FCG 3. PREDICATE DEVICE K853312 ARGON CUT BIOPSY NEEDLES, VARIOUS SIZES K133948 BARD(R) MAX‐CORE(R) DISPOSABLE CORE INSTRUMENT K160316, Biopsy Devices and Accessories The predicate devices K133948 and K16031…
Bard Peripheral Vascular, Inc.20147
*K160316SemiCut Semi-automatic Biopsy Needle, Themy Automatic Disposable Biopsy Device, Palium…
Summary page 4
…s II Product Code: KNW FCG 3. PREDICATE DEVICE K853312 ARGON CUT BIOPSY NEEDLES, VARIOUS SIZES K133948 BARD(R) MAX‐CORE(R) DISPOSABLE CORE INSTRUMENT K160316, Biopsy Devices and Accessories The predicate devices K133948 and K160316 had been subject to a non‐design related recall. 4.…
M.D.L. S.R.L.20161

What descends from it?

No later submission names this one as a predicate yet.

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?

  • The line of descent spans 29 years and passes through 5 companies; a new generation was cleared every 5.6 years on median.
  • 2 of the 8 ancestors have a recall of any class.

How does its category compare?

All KNW devices

KNW Instrument, Biopsy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.

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 Shengwei Biopsy needle consist of Model 121 Biopsy Needle, Model 111/112 Biopsy Needle, and Model 131 Disposable Coaxial Biopsy Needle. These devices are indicated for use as follows: Model 121 Biopsy Needle is intended for obtaining percutaneous or surgical histological core samples from soft tissues such as breast, kidney, liver, lung and various soft tissue masses. The device is not intended for use in bone. Model 111/112 Biopsy Needle is intended…

Read the full statement (226 words)

The Shengwei Biopsy needle consist of Model 121 Biopsy Needle, Model 111/112 Biopsy Needle, and Model 131 Disposable Coaxial Biopsy Needle. These devices are indicated for use as follows:

Model 121 Biopsy Needle is intended for obtaining percutaneous or surgical histological core samples from soft tissues such as breast, kidney, liver, lung and various soft tissue masses. The device is not intended for use in bone.

Model 111/112 Biopsy Needle is intended for obtaining core biopsy from samples soft tissues such as kidney, liver, prostate and various soft tissue masses. The device is not intended for use in bone.

Model 111/112 Biopsy Needle is also indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. It is designed to provide breast tissue for histologic examination with partial or complete removal of the abnormality.

Model 131 Disposable Coaxial Biopsy Needle is intended for use with biopsy needle during soft tissue core biopsy procedures. The device is not intended for use in bone.

The extent of histological abnormality cannot be reliably determined from it mammographic appearance. Therefore the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histological abnormality (e.g. malignancy). When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.

Indications for use as stated in the FDA summary.

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/K214063 · printed Nov 6, 2026

Cite this page

510(k) Report. “K214063: Model 121 Biopsy Needle, Model 111 Biopsy Needle, Model 112 Biopsy Needle, and Model 131 Disposable Coaxial 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/K214063

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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