510(k) Report

FDA applicant

Medrad, Inc.

Indianola, PA105 decisions1976–201426 recalls

FDA records 105 decisions for Medrad, Inc. (Indianola, PA) from 1976 to 2014: 105 510(k) clearances. Most are in product codes DXT (Injector And Syringe, Angiographic) and MOS (Coil, Magnetic Resonance, Specialty). Its devices cite 78 predicates, 43 of them its own earlier devices. 26 recalls are linked to its devices.

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 Medrad, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2007: 22008: 32009: 12010: 12011: 42012: 22013: 22014: 1
2007high 4 (2011) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

1in 2026

2010: 22011: 22012: 22013: 12014: 12015: 32016: 22017: 12018: 32022: 12026 (partial year): 1
2007high 3 (2015) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Medrad, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • DXTInjector And Syringe, Angiographic32decisions
  • MOSCoil, Magnetic Resonance, Specialty18decisions
  • LNHSystem, Nuclear Magnetic Resonance Imaging16decisions
  • FRNPump, Infusion6decisions
  • MCWCatheter, Peripheral, Atherectomy3decisions
  • DQOCatheter, Intravascular, Diagnostic3decisions

Also: LLZ (3), QEZ (3), DQX (3), FPK (2), JAK (2), JAA (2).

Whose devices does it build on?

Its devices cite 78 predicates; 43 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 89 times; 43 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.

  • K033881Medrad Stellant CT Injector System with Imaging System Interface ModuleMedrad, Inc. · 20045cite it
  • K032771Medrad Continuum MR Infusion SystemMedrad, Inc. · 20034cite it
  • K022431Medrad Transfer SetMedrad, Inc. · 20024cite it
  • K934086Medrad Envision CT Injector and Qwik Fit SyringeMedrad, Inc. · 19954cite it
  • K021988Medrad Continuum MR Compatible Infusion SystemMedrad, Inc. · 20023cite it
  • K993728Medrad Envision CT Injector SystemMedrad, Inc. · 19993cite it

What has FDA decided for it lately?

  • K133023Jetstream XC 2.4/3.4; Jetstream XC 2.1/3.0; Jetstream SC 1.85; Jetstream SC 1.6Medrad, Inc. · 20141 recall
  • K130381Angiojet Ultra Power Pulse KitMedrad, Inc. · 2013
  • K130637Jetstream XC 2.4/3.4 System; Jetstream XC 2.1/3.0 System; Jetstream SC 1.85 System; Jetstream SC 1.6 SystemMedrad, Inc. · 2013
  • K122916Jetstream Navitus L System Jeystream Navitus System Jetstream G3 SF System Jetstream SF 1.6 SystemMedrad, Inc. · 2012
  • K113363Angiojet Solent Dista Thrombectomy SetMedrad, Inc. · 20121 recall
  • K113133Medrad Mark 7 Arterion (Pedestal System), (Table Mount System), Medrad Mark 7 Arterion Arterion SyringeMedrad, Inc. · 2011
  • K113428Angiojet Ultra DVX Thrombectomy SetMedrad, Inc. · 2011
  • K112086Medrad Mark 7 Arterion (Pedestal System / Table Mount System), Medrad Mark 7 Arterion SyringeMedrad, Inc. · 20111 recall

All 105 as Medrad, Inc. →

What has been recalled?

26 recalls linked to its devices; the latest:

  • K050456Avanta Multi-Patient Administration Tube Sets (AVA 500 MPAT (Part 2 of 2)) used with the…Apr 24, 2026Class II
  • K100798Source Administration Set (SAS) used with the Medrad Intego PET Infusion System, Sterile…Nov 30, 2022Class II
  • K112086MAVIG Portegra or Portegra2 Overhead Counterpoise System (OCS) used in conjunction with…Dec 14, 2018Class II
  • K944983Overhead Counterpoise Systems (OCS), OCS CONF,STD CEIL MNT, STD HORZ ARM, Catalog # OCS…Jun 28, 2018Class II
  • K944983Overhead Counterpoise Systems (OCS) OCS CONF an accessory device for use with Bayer…Jun 28, 2018Class II
  • K133023The JETSTREAM is a rotational atherectomy catheter system designed for use in debulking…Apr 5, 2017Class II

Other applicant names beginning “Medrad”

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

Medrad Interventional/Possis 2Medrad, Inc. / Bayer Medical Care, Inc. 2Medrad/Technology For People 1