510(k) Report

FDA applicant

Atrion Medical Products, Inc.

Arab, AL9 decisions1997–20060 recalls

FDA records 9 decisions for Atrion Medical Products, Inc. (Arab, AL) from 1997 to 2006: 9 510(k) clearances. Most are in product codes OKS (Lacrimal Stents And Intubation Sets) and KOE (Dilator, Urethral). Its devices cite 15 predicates, 3 of them its own earlier devices. No recall is 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 Atrion Medical Products, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Atrion Medical Products, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Atrion Medical Products, Inc.’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?

  • OKSLacrimal Stents And Intubation Sets2decisions
  • KOEDilator, Urethral2decisions
  • MAVSyringe, Balloon Inflation1decision
  • CAZAnesthesia Conduction Kit1decision
  • FMINeedle, Hypodermic, Single Lumen1decision
  • EIAUnit, Operative Dental1decision

Also: DXT (1).

Whose devices does it build on?

Its devices cite 15 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 10 times; 3 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.

  • K032840Atrion Medical QL Inflation DeviceAtrion Medical Products, Inc. · 20045cite it
  • K972964Atrion Medical Balloon Catheter Inflation DeviceAtrion Medical Products, Inc. · 19973cite it
  • K020333Atrion Medical QL Fluid Dispensing SyringeAtrion Medical Products, Inc. · 20022cite it

What has FDA decided for it lately?

  • K060643QL Locking SyringeAtrion Medical Products, Inc. · 2006
  • K043249Atrion Needlevise Large-Bore Sharps Securing DeviceAtrion Medical Products, Inc. · 2005
  • K041158Atrion Epidural Anesthesia Kit with Atrion Needlevise Sharps Securing SystemAtrion Medical Products, Inc. · 2004
  • K032840Atrion Medical QL Inflation DeviceAtrion Medical Products, Inc. · 2004
  • K020333Atrion Medical QL Fluid Dispensing SyringeAtrion Medical Products, Inc. · 2002
  • K973633Atrion Medical Products Lacrimal Intubation SetAtrion Medical Products, Inc. · 1998
  • K973872Atrion Medical Coated Lacrimal Intubation SetAtrion Medical Products, Inc. · 1998
  • K972964Atrion Medical Balloon Catheter Inflation DeviceAtrion Medical Products, Inc. · 1997

All 9 as Atrion Medical Products, Inc. →