510(k) Report

510(k) · Cleared

Cleared

24 FR. Left Heart Vent Catheter with Pressure Monitoring Line, Model 12524

K012143510(k) SpecialCleared Oct 24, 2001106-day reviewClass II21 CFR 870.1280

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

Medtronic Cardiac Surgical Products · DRA Catheter, Steerable

Cleared on Oct 24, 2001 as substantially equivalent to K834352 (Dlp, Inc., 1984) and 2 other predicates after a 106-day review. Its family tree reaches back 1 generation to 1983. 1 of the 4 devices in its family, counting itself, has a Class I recall.

Decided
Oct 24, 2001
Review
106 days
Class
Class II
Product code
DRA
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K831591 (1983). 3 ancestors in all. No later device cites it as a predicate yet. 1 of the 4 devices in this family, counting this one, has a Class I recall.

Other ancestors, by year cleared 1984: 2 other ancestors, 1 with a Class I recall1K831591 · Aortic Root Cannula W/Integral Press · Dlp, Inc. · 1983 · recalled19801985199019952000
Other ancestors, by generation 1 generation back: 2 other ancestors, 1 with a Class I recall1 K831591 · Aortic Root Cannula W/Integral Press · Dlp, Inc. · 1983 · recalled0
  1. Root · 1 generation backK831591 Aortic Root Cannula W/Integral PressDlp, Inc. · 1983 · Recalled
  2. This deviceK012143 24 FR. Left Heart Vent Catheter with Pressure Monitoring Line, Model…Medtronic Cardiac Surgical Products · 2001

Class I recalls in this family

  • K834039 Infant Vent Catheter 12001 W/Side Ventdirect predicate · 1984
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K831591Aortic Root Cannula W/Integral PressDlp, Inc.19832
0 (this device)K01214324 FR. Left Heart Vent Catheter with Pressure Monitoring Line, Model 12524Medtronic Cardiac Surgical Products2001—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198421
FIG. 1 — Lineage of K012143, 1983–2001Source: 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.

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 DRA device

  1. #1 K262165 FARADRIVE™ Steerable Sheath (M004PF21M402)score 13.2 · 6 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? (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
*K834352Adult Vent Catheter
Summary page 2
…FAX: 616-643-1017 DEVICE NAME 24 Fr. Left Heart Vent Catheter w/ Pressure Monitoring Line (12524) NAME OF PREDICATED OR LEGALLY MARKETED DEVICE Adult Vent Catheter (K834352) Aortic Root Cannula with Pressure Monitoring Line (K831591) DESCRIPTION OF DEVICE The 24 Fr. Left Heart Vent Catheter with Pre…
Dlp, Inc.19842
*K834039Infant Vent Catheter 12001 W/Side Vent
Summary page 3
…Fr. Left Heart Vent Catheter with Pressure Monitoring Line is being compared to the following Marketed Devices: ¢ Adult Vent Catheter (K834352) ¢ Infant Vent Catheter (K834039) ¢ Aortic Root cannula(s) with Integral Pressure Monitoring Line (K831591) The 24 Fr. Left Heart Vent Catheter with Pressure Mon…
Dlp, Inc.1984Class I
*K831591Aortic Root Cannula W/Integral Press
Summary page 2
…heter w/ Pressure Monitoring Line (12524) NAME OF PREDICATED OR LEGALLY MARKETED DEVICE Adult Vent Catheter (K834352) Aortic Root Cannula with Pressure Monitoring Line (K831591) DESCRIPTION OF DEVICE The 24 Fr. Left Heart Vent Catheter with Pressure Monitoring Line is designed for use in venting the lef…
Dlp, Inc.19832

Also cleared against K834352: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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.

  • K834039Infant Vent Catheter 12001 W/Side VentDlp, Inc. · 1984 · Direct predicate · ◆ in the 1984 ancestors bar of FIG. 13 Class I recalls

What does this lineage say?

  • 3 of the 3 ancestors have a recall of any class; 1 has a Class I recall.
  • 2 other devices also cite its predicate K834352.

How does its category compare?

All DRA devices

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

FDA decisions per year · DRA

1in 2025

2007: 12008: 12009: 22010: 32011: 12012: 42014: 12015: 12016: 42017: 22018: 12019: 22020: 12021: 12022: 22023: 32025: 12026 (partial year): 1
2007high 4 (2012) · low 0 (2013)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DRA

89in 2023

2010: 29 days median2012: 70 days median2016: 123 days median2023: 89 days median
2007high 123 (2016) · low 29 (2010)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DRA

4so far in 2026, the most since 2007

2008: 12011: 12026 (partial year): 4
2007high 4 (2026) · low 0 (2007)2026

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

Adverse event reports per year · DRA

4,018in 2025

2007: 62008: 232009: 52010: 22011: 1552012: 892013: 1132014: 2122015: 3502016: 4812017: 6252018: 6332019: 7002020: 7032021: 7412022: 6522023: 7882024: 1,9622025: 4,018
2007high 4,018 (2025) · low 2 (2010)2025

MAUDE reports naming product code DRA, 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
20071—06
20081—123
20092—05
201032902
20111—1155
2012470089
20130—0113
20141—0212
20151—0350
201641230481
20172—0625
20181—0633
20192—0700
20201—0703
20211—0741
20222—0652
20233890788
20240—01,962
20251—04,018
20261—4—

What is it indicated for?

The 24 Fr. Left Heart Vent Catheter with Pressure Monitoring Line is intended for

venting the left heart during cardiopulmonary bypass surgery.

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

Also cleared against K834352

2 other devices cite the same predicate.

  • K200289Michler-Kapp Cardiovascular Vent CatheterKapp Surgical Instrument, Inc. · 2021
  • K170488Peak Left Ventricular Vent Cannula, 20 Fr.; Peak Left Ventricular Vent Cannula, 18 Fr; Peak Left Ventricular…Surge Cardiovascular · 2017

More from Medtronic Cardiac Surgical Products

7 FDA decisions under this applicant name. See the company

  • K022272Malleable Single Stage Venous Cannula, Models 68112-68140 (15 Total Codes)Medtronic Cardiac Surgical Products · 20033 recalls
  • K013013Medtronic DLP Arterial Cannula with 3D Tip - 22 FR.Medtronic Cardiac Surgical Products · 20011 recall
  • K010737Select Cap Arterial Cannula with Pressure Monitoring Line, Model…Medtronic Cardiac Surgical Products · 20011 recall
  • K000776Medtronic DLP Arterial Cannulae with 3D TipMedtronic Cardiac Surgical Products · 20011 recall
  • K994171Medtronic Aortocoronary Shunt and Separately Packaged Arteriotomy CannulaeMedtronic Cardiac Surgical Products · 2000

Recent decisions in DRA

The DRA category page

  • K262165FARADRIVE™ Steerable Sheath (M004PF21M402)Boston Scientific Corporation · 2026
  • K250529Globe Introducer (601-01001)Kardium, Inc. · 2025
  • K233248FARADRIVE™ Steerable SheathBoston Scientific Corporation · 20233 recalls
  • K232321FlexCath Contour™ Steerable SheathMedtronic, Inc. · 2023
  • K223824POLARSHEATH™ Steerable Sheath 12F (UPN:M004CRBS3150), POLARMAP™ Circular Mapping Catheter…Boston Scientific Corporation · 20231 Class I recall

https://510kreport.com/device/K012143 · printed Nov 6, 2026

Cite this page

510(k) Report. “K012143: 24 FR. Left Heart Vent Catheter with Pressure Monitoring Line, Model 12524.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012143

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026