510(k) Report

510(k) · Cleared

Cleared

Argon Cut Biopsy Needles, Various Sizes

K853312510(k) TraditionalCleared Sep 12, 198536-day reviewClass I21 CFR 878.4800

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

Argon Medical Corp. · DWO Needle, Biopsy, Cardiovascular

Cleared on Sep 12, 1985 after a 36-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided
Sep 12, 1985
Review
36 days
Class
Class I
Product code
DWO
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2022: 1 descendant cleared1990200020102020
  1. This deviceK853312 Argon Cut Biopsy Needles, Various SizesArgon Medical Corp. · 1985
  2. Descendant · cites it directly · 0 of its ownK214063 Model 121 Biopsy Needle, Model 111 Biopsy Needle, Model 112 Biopsy…Guangzhou Shengwei Medical Devices Co., Ltd. · 2022

Most influential descendants

Showing 1 of 1 · See all
  • K214063Model 121 Biopsy Needle, Model 111 Biopsy Needle, Model 112 Biopsy Needle, and Model 131…Guangzhou Shengwei Medical Devices Co., Ltd. · 2022 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K853312Argon Cut Biopsy Needles, Various SizesArgon Medical Corp.1985—
+1K214063Model 121 Biopsy Needle, Model 111 Biopsy Needle, Model 112 Biopsy Needle, and…Guangzhou Shengwei Medical Devices Co., Ltd.2022—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202210
FIG. 1 — Lineage of K853312, 1985–2022Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

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  • Recall history across each candidate’s familyin the report
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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? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K214063Model 121 Biopsy Needle, Model 111 Biopsy Needle, Model 112 Biopsy Needle, and Model 131…Guangzhou Shengwei Medical Devices Co., Ltd.20220

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, K214063 (Guangzhou Shengwei Medical Devices Co., Ltd., 2022) has gone furthest, with 0 descendants of its own.

How does its category compare?

All DWO devices

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

FDA decisions per year · DWO

FDA has decided no DWO device since 2007.

Median 510(k) review, days · DWO

Too few DWO 510(k)s in any year since 2007 to give a median.

Recalls per year · DWO

7in 2018

2018: 7
2007high 7 (2018) · low 0 (2007)2026

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

Adverse event reports per year · DWO

6in 2024

2007: 32008: 72009: 92010: 72011: 32012: 92013: 112014: 32015: 82016: 62017: 42018: 92024: 6
2007high 11 (2013) · low 0 (2019)2025

MAUDE reports naming product code DWO, 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
20070—03
20080—07
20090—09
20100—07
20110—03
20120—09
20130—011
20140—03
20150—08
20160—06
20170—04
20180—79
20190—00
20200—00
20210—00
20220—00
20230—00
20240—06
20250—00
20260—0—

More from Argon Medical Corp.

27 FDA decisions under this applicant name. See the company

  • K904994Closed System Flush SetArgon Medical Corp. · 1991
  • K895511Catheter Balloon Dilator Pressure GaugeArgon Medical Corp. · 1990
  • K894157ObturatorArgon Medical Corp. · 1989
  • K891022Introducer for Ptca Guiding CathetersArgon Medical Corp. · 1989
  • K884375Translumbar Aortography Needle CatheterArgon Medical Corp. · 1989

Recent decisions in DWO

The DWO category page

  • K933364Promed Biopsy NeedleVlv Associates, Inc. · 1994
  • K921418Ultra-Core Biopsy NeedlesMedical Device Technologies, Inc. · 1992
  • K913815Automated Biopsy Device, ModificationHart Enterprises, Inc. · 1991
  • K890925Manan Bone Marrow Biopsy NeedleManan Medical Products, Inc. · 19897 recalls
  • K885145Medsurg Greene NeedleMedsurg Industries, Inc. · 1989

https://510kreport.com/device/K853312 · printed Nov 4, 2026

Cite this page

510(k) Report. “K853312: Argon Cut Biopsy Needles, Various Sizes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K853312

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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