510(k) Report

FDA applicant

Dlp, Inc.

Grand Rapids, MI56 decisions1979–199748 recalls

FDA records 56 decisions for Dlp, Inc. (Grand Rapids, MI) from 1979 to 1997: 56 510(k) clearances. Most are in product codes DWF (Catheter, Cannula And Tubing, Vascular…) and GAA (Needle, Aspiration And Injection, Disposable). Its devices cite 1 predicate, 0 of them its own earlier devices. 48 recalls are linked to its devices, 3 Class I.

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

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Dlp, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Dlp, Inc. since 2007.

Recalls per year

9in 2026

2008: 42010: 12011: 82013: 12015: 12016: 42017: 52021: 22024: 92025: 3, 3 Class I2026 (partial year): 9
2007high 9 (2024) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Dlp, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass22decisions
  • GAANeedle, Aspiration And Injection, Disposable5decisions
  • DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass5decisions
  • KNWInstrument, Biopsy3decisions
  • DQXWire, Guide, Catheter2decisions
  • DWSInstruments, Surgical, Cardiovascular2decisions

Also: DTR (1), GEI (1), DYB (1), DQT (1), GCY (1), GBP (1).

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 63 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K790565Aortic Root CannulaDlp, Inc. · 19798cite it
  • K791498Adapter-Y Type/Coronary PerfusionDlp, Inc. · 19794cite it
  • K845045Venous Return Catheter SS-1Dlp, Inc. · 19854cite it
  • K964445Octopus Tissue Stabilizer (28001/28002/28003/28004/28005/28006)Dlp, Inc. · 19974cite it
  • K840002Arterial Cannula Curved Beveled TipDlp, Inc. · 19843cite it
  • K901074Code #94315 Retrograde Coronary Sinus Perf CannulaDlp, Inc. · 19903cite it

What has FDA decided for it lately?

  • 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
  • K915268Catheter Two Stage Venous ReturnDlp, Inc. · 1992
  • K913077Lancaster Cooling Jacket, Cat. Code #13500/13501Dlp, Inc. · 1992
  • K914608Breast Les Local Wire ST. 48219/49220/48119/48120Dlp, Inc. · 1992

All 56 as Dlp, Inc. →

What has been recalled?

48 recalls linked to its devices; the latest:

  • K860149Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94665…Apr 21, 2026Class II
  • K860149Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94113T…Apr 21, 2026Class II
  • K860149Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94215T…Apr 21, 2026Class II
  • K860149Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913L…Apr 21, 2026Class II
  • K860149Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94913…Apr 21, 2026Class II
  • K860149Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94965…Apr 21, 2026Class II