510(k) Report

510(k) · Cleared

Cleared

Translumbar Aortography Needle Catheter

K884375510(k) TraditionalCleared Jan 11, 198985-day reviewClass II21 CFR 870.1300

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

Argon Medical Corp. · DQR Cannula, Catheter

Cleared on Jan 11, 1989 after an 85-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided
Jan 11, 1989
Review
85 days
Class
Class II
Product code
DQR
Recalls
None
Predicates
0

2 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2005: 1 descendant cleared2011: 1 descendant cleared1990200020102020
  1. This deviceK884375 Translumbar Aortography Needle CatheterArgon Medical Corp. · 1989
  2. Descendant · cites it directly · 1 of its ownK051280 Medcomp Split Cath IIMedcomp · 2005
  3. Descendant · 2 generations on · 0 of its ownK111651 Split Cath IiiMedical Components, Inc. · 2011 · Recalled

Most influential descendants

Showing 2 of 2 · See all
  • K051280Medcomp Split Cath IIMedcomp · 2005 · cites it directly1descendant
  • K111651Split Cath IiiMedical Components, Inc. · 2011 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K884375Translumbar Aortography Needle CatheterArgon Medical Corp.1989—
+1K051280Medcomp Split Cath IIMedcomp2005—
+2K111651Split Cath IiiMedical Components, Inc.20111

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
201110
FIG. 1 — Lineage of K884375, 1989–2011Source: 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.

Planning a device in DQR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • 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? (2)

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

NumberDeviceApplicantDecidedDescendants
K051280Medcomp Split Cath IIMedcomp20051

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, K051280 (Medcomp, 2005) has gone furthest, with 1 descendant of its own.

How does its category compare?

All DQR devices

DQR Cannula, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DQR

1in 2013

2008: 12013: 1
2007high 1 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQR

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

Recalls per year · DQR

1in 2020

2020: 1
2007high 1 (2020) · low 0 (2007)2026

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

Adverse event reports per year · DQR

6in 2025

2007: 172008: 82009: 272010: 242011: 72012: 72013: 62014: 82015: 402016: 752017: 292018: 172019: 162020: 42021: 112022: 272023: 362024: 72025: 6
2007high 75 (2016) · low 4 (2020)2025

MAUDE reports naming product code DQR, 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—017
20081—08
20090—027
20100—024
20110—07
20120—07
20131—06
20140—08
20150—040
20160—075
20170—029
20180—017
20190—016
20200—14
20210—011
20220—027
20230—036
20240—07
20250—06
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
  • K882221Over the Needle Catheter, Arterial Catheter NeedleArgon Medical Corp. · 1988

Recent decisions in DQR

The DQR category page

  • K131446Integra Jarit Heparin Cannulas, Injectors, and NeedlesIntegra LifeSciences Corporation · 2013
  • K07355918 FR. Rmi Arterial Perfusion Cannula II, 20 FR. Rmi Arterial Perfusion Cannula IIEdwards Lifesciences Research Medical · 20082 Class I recalls
  • K051655Angiodynamics, Inc., Micro Access KitsAngioDynamics, Inc. · 20059 recalls
  • K030398Cardiacassist Transseptal Cannula Set, Model 5132-6221Cardiacassist, Inc. · 2003
  • K960098Rmi Internal Mammary Artery CannulaResearch Medical, Inc. · 1996

https://510kreport.com/device/K884375 · printed Nov 4, 2026

Cite this page

510(k) Report. “K884375: Translumbar Aortography Needle Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K884375

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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