510(k) Report

FDA applicant

Atrium Medical Corp.

Hudson, NH70 decisions1981–2024155 recalls

FDA records 70 decisions for Atrium Medical Corp. (Hudson, NH) from 1981 to 2024: 69 510(k) clearances and 1 original PMA approval. Most are in product codes DSY (Prosthesis, Vascular Graft, Of 6mm And Greater…) and FTL (Mesh, Surgical, Polymeric). Its devices cite 14 predicates, 14 of them its own earlier devices. 155 recalls are linked to its devices, 3 Class I.

FDA’s records also spell it “Atrium Medical Corporation”.

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 Atrium Medical Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2007: 22008: 32009: 22010: 32011: 22012: 22013: 22015: 22021: 12023: 12024: 1
2007high 3 (2008) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

68in 2024

2008: 172013: 272014: 12015: 52016: 152017: 42018: 12021: 32022: 3, 1 Class I2023: 10, 2 Class I2024: 68
2007high 68 (2024) · low 0 (2007)2026

Class I Class II/III not classified

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

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

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Which product codes does it file in?

  • DSYProsthesis, Vascular Graft, Of 6mm And Greater Diameter18decisions
  • FTLMesh, Surgical, Polymeric14decisions
  • CACApparatus, Autotransfusion10decisions
  • KDQBottle, Collection, Vacuum8decisions
  • DYFProsthesis, Vascular Graft, Of Less Then 6mm Diameter4decisions
  • DQYCatheter, Percutaneous3decisions

Also: DXE (3), JCT (2), DXZ (2), DWD (1), BTA (1), GBS (1).

Who builds on its devices?

Later devices cite its devices 33 times; 14 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.

  • K992991Atrium Medical Corporation Advanta Ptfe Facial ImplantAtrium Medical Corp. · 20004cite it
  • K002093Atrium Lite MeshAtrium Medical Corp. · 20004cite it
  • K930669Atrium Polypropylene MeshAtrium Medical Corp. · 19933cite it
  • K043140Express and Oasis Chest DrainAtrium Medical Corp. · 20042cite it
  • K050311Atrium Medical Corporation C-Qur MeshAtrium Medical Corp. · 20062cite it
  • K071923Ptfe Flixene Graduated Wall GraftAtrium Medical Corp. · 20072cite it

What has FDA decided for it lately?

  • K231972Advanta VXT Vascular Graft, Flixene Vascular GraftAtrium Medical Corporation · 2024
  • P120003iCast Covered Stent SystemAtrium Medical Corp. · 20231 recall
  • K201305Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction Water Seal Chest Drain…Atrium Medical Corporation · 20211 Class I recall
  • K151386C-QUR, C-QUR FX, C-QUR TacShield, C-QUR V-Patch, C-QUR CentriFX, C-QUR MosaicAtrium Medical Corporation · 2015
  • K151437ProLite Mesh, ProLite Ultra Mesh, ProLoop Mesh PlugAtrium Medical Corporation · 20151 recall
  • K130142Flixene Ifg Vascular GraftAtrium Medical Corporation · 2013
  • K130131Edrain Chest Drainage SystemAtrium Medical Corp. · 2013
  • K122138Atrium Flixene Ifg Vascular GraftAtrium Medical Corp. · 20121 recall

All 64 as Atrium Medical Corp. →All 6 as Atrium Medical Corporation →

What has been recalled?

155 recalls linked to its devices; the latest:

  • K060124FLIXENE, 7X50, 1GDS, GW. Single-Ended Slider GDS. Vascular graftMay 3, 2024Class II
  • K060124FLIXENE, 7X50, 1GDS, STR. Single-Ended Slider GDS. Vascular graftMay 3, 2024Class II
  • K060124FLIXENE, 4-7X45, 2GDS, GWT. Double-Ended Slider GDS. Vascular graftMay 3, 2024Class II
  • K992960ADVANTA VXT, 8X70, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graftMay 3, 2024Class II
  • K992960ADVANTA VXT, 8X70, 1GDS, NH, STR-TW. Single-Ended Slider GDS. Vascular graftMay 3, 2024Class II
  • K992960ADVANTA VXT, 7X50, 1GDS, FH, STR-SW. Single-Ended Slider GDS. Vascular graftMay 3, 2024Class II