510(k) Report

FDA applicant

Oscor, Inc.

Palm Harbor, FL49 decisions1979–202142 recalls

FDA records 49 decisions for Oscor, Inc. (Palm Harbor, FL) from 1979 to 2021: 49 510(k) clearances. Most are in product codes DTB (Permanent Pacemaker Electrode) and DYB (Introducer, Catheter). Its devices cite 18 predicates, 6 of them its own earlier devices. 42 recalls are linked to its devices, 5 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 Oscor, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2007: 22008: 32009: 12010: 22012: 42013: 12014: 42015: 22021: 1
2007high 4 (2012) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

3in 2026

2008: 22011: 12012: 12016: 302017: 2, 2 Class I2021: 22026 (partial year): 3, 3 Class I
2007high 30 (2016) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Oscor, 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?

  • DTBPermanent Pacemaker Electrode20decisions
  • DYBIntroducer, Catheter13decisions
  • LDFElectrode, Pacemaker, Temporary4decisions
  • DTDPacemaker Lead Adaptor4decisions
  • DRCTrocar2decisions
  • DTEPulse-Generator, Pacemaker, External1decision

Also: DQX (1), DYG (1), IKD (1), DTG (1), DQO (1).

Whose devices does it build on?

Its devices cite 18 predicates; 6 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 15 times; 6 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.

  • K122084Introducer Set, Model Adelante-S SeriesOscor, Inc. · 20122cite it
  • K122960Steerable Guiding Sheath, Model Adelante DestinoOscor, Inc. · 20121cites it
  • K210627Breezeway IIOscor, Inc. · 20211cites it
  • K081052Occlusion Balloon Catheter, Model VenosOscor, Inc. · 20081cites it
  • K140406Destino Twist, Steerable Guiding SheathOscor, Inc. · 20141cites it
  • K073100Introducer Sets, Models Adelante and Adelante-SOscor, Inc. · 20071cites it

What has FDA decided for it lately?

  • K210627Breezeway IIOscor, Inc. · 2021
  • K151951Destino ReachOscor, Inc. · 2015
  • K143463IS4/DF4 Port PlugOscor, Inc. · 2015
  • K140917Introducer, Model Adelante MagnumOscor, Inc. · 2014
  • K140406Destino Twist, Steerable Guiding SheathOscor, Inc. · 20141 recall
  • K130633Introducer Sets, Model Adelante RadialOscor, Inc. · 2014
  • K130843Safesept Needle Free Transseptal Trocar GuidewireOscor, Inc. · 2014
  • K130104Guidewire, Pursuer SeriesOscor, Inc. · 2013

All 49 as Oscor, Inc. →

What has been recalled?

42 recalls linked to its devices; the latest:

  • K122084Abiomed REF: 0052-3006, Introducer Kit for Impella Hemostatic Peel Away Introducer…Jun 10, 2026Class I
  • K122084Abiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel Away Introducer…Jun 10, 2026Class I
  • K122084Abiomed REF: 0052-3021, Introducer Kit for Impella Hemostatic Peel Away Introducer…Jun 10, 2026Class I
  • K140406Destino Twist 14F (also branded as Guidestar 14F)Dec 22, 2021Class II
  • K122084AngioDynamics Safe Sheath Ultralite - Vascular Introducer/Catheter Introducer Catalogue…Feb 22, 2021Class II
  • K070926ATAR Disposable Extension Cable, sold under brand names: ATAR Disposable Series, ATAR…Mar 31, 2017Class I

Other applicant names beginning “Oscor”

FDA records each applicant name separately; these may or may not be the same firm.

Oscor Medical Corp. 31