510(k) Report

FDA applicant

Namic

Glens Falls, NY8 decisions1979–19967 recalls

FDA records 8 decisions for Namic (Glens Falls, NY) from 1979 to 1996: 8 510(k) clearances. Most are in product codes DRS (Transducer, Blood-Pressure, Extravascular) and DQO (Catheter, Intravascular, Diagnostic). Its devices cite 1 predicate, 0 of them its own earlier devices. 7 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 Namic’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Namic since 2007.

Recalls per year

3in 2026

2008: 12021: 22026 (partial year): 3, 3 Class I
2007high 3 (2026) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Namic 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?

  • DRSTransducer, Blood-Pressure, Extravascular2decisions
  • DQOCatheter, Intravascular, Diagnostic2decisions
  • DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass1decision
  • FPASet, Administration, Intravascular1decision
  • DQYCatheter, Percutaneous1decision
  • MAVSyringe, Balloon Inflation1decision

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 4 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.

  • K822100High Pressure Contrast Injection LineNamic · 19822cite it
  • K951722Perceptor Compensator Morse ManifoldNamic · 19961cites it
  • K953676Breeze Digital Inflation DeviceNamic · 19961cites it

What has FDA decided for it lately?

  • K953676Breeze Digital Inflation DeviceNamic · 1996
  • K951722Perceptor Compensator Morse ManifoldNamic · 1996
  • K921322Morse Anesthesia ManifoldNamic · 1993
  • K822100High Pressure Contrast Injection LineNamic · 1982
  • K813549Continuous Flush DeviceNamic · 1982
  • K790082Arterial Extension SetNamic · 1979
  • K790083Catheter, Arterial LineNamic · 1979
  • K782095Stopcocks, ManifoldsNamic · 19793 Class I recalls

All 8 as Namic →

What has been recalled?

7 recalls linked to its devices; the latest:

  • K782095Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038301…Mar 24, 2026Class I
  • K782095Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038402…Mar 24, 2026Class I
  • K782095Namic Angiographic Manifold, custom, Medline Product Number/SKU 64038200…Mar 24, 2026Class I
  • K842829NAMIC Manifolds. (1) NAMIC Angiographic MANIFOLD, Medium Pressure, REF 64038301, UPN…Aug 6, 2021Class II
  • K842829NAMIC Stopcocks: (1) NAMIC STOPCOCK, 200 psi (14 bar), REF 70015002, UPN H965700150021…Aug 6, 2021Class II
  • K782095NAMIC Custom Angiographic Kit, Right Heart Kit, REF/Catalog # 60190254, Sterile, and…Aug 6, 2008