510(k) Report

510(k) · Cleared

Recalled · Class II · 2026

Venous Perfusion Cannula W/Cuff Cat. NO. 94015

K860149510(k) TraditionalCleared Mar 31, 198675-day reviewClass II21 CFR 870.4210Recalls 9

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

Dlp, Inc. · DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

Cleared on Mar 31, 1986 after a 75-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it. It has been recalled 9 times.

Decided
Mar 31, 1986
Review
75 days
Class
Class II
Product code
DWF
Recalls
9
Predicates
0

5 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2026: 1 descendant cleared2003: 1 descendant cleared2009: 1 descendant cleared2013: 2 descendants cleared1990200020102020
  1. This deviceK860149 Venous Perfusion Cannula W/Cuff Cat. NO. 94015Dlp, Inc. · 1986
  2. Descendant · cites it directly · 2 of its ownK030696 Retrograde Coronary Sinus Perfusion Cannula with NO Pressure Line…Medtronic Perfusion Systems · 2003
  3. Descendant · cites it directly · 0 of its ownK253203 Retrograde Coronary Sinus Perfusion CannulaeMedtronic, Inc. · 2026
  4. Descendant · 2 generations on · 0 of its ownK132995 DLP Retrograde Coronary Sinus Perfusion Cannula Without Pressure…Medtronic, Inc. · 2013
  5. Descendant · 2 generations on · 0 of its ownK123762 DLP Retrograde Coronary Sinus Perfusion Cannula with Auto-Inflate CuffMedtronic, Inc. · 2013
  6. Descendant · cites it directly · 0 of its ownK090869 Mircsp (Minimally Invasive Retrograde Coronary Sinus Perfusion)…Medtronic Perfusion Systems · 2009

Most influential descendants

Showing 5 of 5 · See all
  • K030696Retrograde Coronary Sinus Perfusion Cannula with NO Pressure Line (15 French, Manual and…Medtronic Perfusion Systems · 2003 · cites it directly2descendants
  • K253203Retrograde Coronary Sinus Perfusion CannulaeMedtronic, Inc. · 2026 · cites it directly0descendants
  • K132995DLP Retrograde Coronary Sinus Perfusion Cannula Without Pressure Monitoring Line, DLP…Medtronic, Inc. · 2013 · 2 generations on0descendants
  • K123762DLP Retrograde Coronary Sinus Perfusion Cannula with Auto-Inflate CuffMedtronic, Inc. · 2013 · 2 generations on0descendants
  • K090869Mircsp (Minimally Invasive Retrograde Coronary Sinus Perfusion) Manual Inflate Cannula…Medtronic Perfusion Systems · 2009 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K860149Venous Perfusion Cannula W/Cuff Cat. NO. 94015Dlp, Inc.1986—
+1K030696Retrograde Coronary Sinus Perfusion Cannula with NO Pressure Line (15 French…Medtronic Perfusion Systems2003—
+1K253203Retrograde Coronary Sinus Perfusion CannulaeMedtronic, Inc.2026—
+2K132995DLP Retrograde Coronary Sinus Perfusion Cannula Without Pressure Monitoring…Medtronic, Inc.2013—
+2K123762DLP Retrograde Coronary Sinus Perfusion Cannula with Auto-Inflate CuffMedtronic, Inc.2013—
+1K090869Mircsp (Minimally Invasive Retrograde Coronary Sinus Perfusion) Manual Inflate…Medtronic Perfusion Systems2009—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200910
201320
202610
FIG. 1 — Lineage of K860149, 1986–2026Source: 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.

Planning a device in DWF? 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 DWF device

  1. #1 K251258 MC2™ Two-Stage Venous Cannula; MC2X™…score 14.6 · 8 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (5)

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

NumberDeviceApplicantDecidedDescendants
K030696Retrograde Coronary Sinus Perfusion Cannula with NO Pressure Line (15 French, Manual and…Medtronic Perfusion Systems20032
K253203Retrograde Coronary Sinus Perfusion CannulaeMedtronic, Inc.20260
K090869Mircsp (Minimally Invasive Retrograde Coronary Sinus Perfusion) Manual Inflate Cannula…Medtronic Perfusion Systems20090

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Apr 21, 2026Class IIZ-2217-2026Packaging process controlCertain lots of product have the potential for a sterile barrier breach.
Apr 21, 2026Class IIZ-2214-2026Packaging process controlCertain lots of product have the potential for a sterile barrier breach.
Apr 21, 2026Class IIZ-2216-2026Packaging process controlCertain lots of product have the potential for a sterile barrier breach.
Apr 21, 2026Class IIZ-2220-2026Packaging process controlCertain lots of product have the potential for a sterile barrier breach.
Apr 21, 2026Class IIZ-2219-2026Packaging process controlCertain lots of product have the potential for a sterile barrier breach.
Apr 21, 2026Class IIZ-2222-2026Packaging process controlCertain lots of product have the potential for a sterile barrier breach.
Apr 21, 2026Class IIZ-2218-2026Packaging process controlCertain lots of product have the potential for a sterile barrier breach.
Apr 21, 2026Class IIZ-2221-2026Packaging process controlCertain lots of product have the potential for a sterile barrier breach.
Apr 21, 2026Class IIZ-2215-2026Packaging process controlCertain lots of product have the potential for a sterile barrier breach.

The 5 latest of 9 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K030696 (Medtronic Perfusion Systems, 2003) has gone furthest, with 2 descendants of its own.

How does its category compare?

All DWF devices

DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DWF

4in 2025

2007: 22008: 62009: 82010: 32011: 52012: 102013: 92014: 142015: 92016: 32017: 52018: 52019: 32020: 32021: 52022: 22023: 22024: 32025: 42026 (partial year): 8
2007high 14 (2014) · low 2 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DWF

89in 2025

2008: 95 days median2009: 148 days median2010: 62 days median2011: 85 days median2012: 110 days median2013: 110 days median2014: 110 days median2015: 46 days median2016: 32 days median2017: 127 days median2018: 30 days median2019: 120 days median2020: 30 days median2021: 358 days median2024: 29 days median2025: 89 days median2026 (partial year): 81 days median
2007high 358 (2021) · low 29 (2024)2026

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

Recalls per year · DWF

4in 2024

2007: 252008: 252009: 212010: 262011: 132012: 372013: 14, 1 Class I2014: 62015: 3, 1 Class I2016: 32017: 2, 1 Class I2018: 102019: 22021: 32024: 42026 (partial year): 20
2007high 37 (2012) · low 0 (2020)2026

Class I (3 since 2007) Class II/III not classified

Adverse event reports per year · DWF

1,020in 2025

2007: 1212008: 1262009: 992010: 1972011: 2122012: 2332013: 2382014: 3252015: 2182016: 1442017: 1012018: 1182019: 1792020: 1422021: 1622022: 2762023: 4702024: 4012025: 1,020
2007high 1,020 (2025) · low 99 (2009)2025

MAUDE reports naming product code DWF, 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
20072—25121
200869525126
200981482199
201036226197
201158513212
20121011037233
2013911014 (1)238
2014141106325
20159463 (1)218
20163323144
201751272 (1)101
201853010118
201931202179
20203300142
202153583162
20222—0276
20232—0470
20243294401
202548901,020
202688120—

More from Dlp, Inc.

56 FDA decisions under this applicant name. See the company

  • K973485Clearview Blower/MisterDlp, Inc. · 19971 recall
  • K964445Octopus Tissue Stabilizer (28001/28002/28003/28004/28005/28006)Dlp, Inc. · 1997
  • K953945Retrograde Coronary Sinus Perfusion Cannula with Elongated & Treaded Cuff & Introducer StyletDlp, Inc. · 19968 recalls
  • K950754Macro Suction Tube Model NO 10061Dlp, Inc. · 1995
  • K934215Contain-orDlp, Inc. · 1994

Recent decisions in DWF

The DWF category page

  • K263092Dual Stage Venous CannulaeSorin Group Italia S.R.L. · 2026
  • K262052Tri Stage Venous CannulaeSorin Group Italia S.R.L. · 2026
  • K260195Elongated One-Piece Arterial (EOPA) 3D™ Arterial CannulaeMedtronic, Inc. · 20262 recalls
  • K250937Venous Return CannulaeLivaNova USA, Inc. · 2026
  • K260043Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C)Smart Reactors · 2026

https://510kreport.com/device/K860149 · printed Nov 4, 2026

Cite this page

510(k) Report. “K860149: Venous Perfusion Cannula W/Cuff Cat. NO. 94015.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K860149

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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