Bio-Pen Calculator

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K860205 ↗

FDA Product Code

LQB

Device Class

Class III

Advisory Committee

Unknown

FDA Decision

SESE Substantially Equivalent

• Ocu-Film Tip Cover

  Class II

  FDA 510(k) K882750 Active Cleared 4 Aug 1988

• Oculab Biometricpen

  Class II

  FDA 510(k) K860061 Active Cleared 10 Mar 1986

• Oculab Tonopen

  Class II

  FDA 510(k) K852774 Active Cleared 20 Aug 1985

• Pach-Pen Calculator

  Class II

  FDA 510(k) K884619 Active Cleared 2 Feb 1989

• Pach-Pen Surgical Drape

  Class II

  FDA 510(k) K862016 Active Cleared 4 Jun 1986

• Oculab Pachpen

  Class II

  FDA 510(k) K860062 Active Cleared 10 Mar 1986

• What clinical scenarios or ophthalmic procedures is the Bio-Pen Calculator designed to assist with?

  The Bio-Pen Calculator is a medical computer and software tool specifically designed to perform calculations relevant to ophthalmic procedures. It aids clinicians in making informed decisions during eye-related diagnostics or treatments, though the exact types of calculations or specific procedures it supports are not detailed in the provided data.

• How is the Bio-Pen Calculator supplied, and is it intended for single-use or reuse?

  The Bio-Pen Calculator is supplied as a standalone unit, meaning it is not packaged as a disposable or single-use item. The data does not specify reuse restrictions or sterility requirements, implying it is intended for repeated use in clinical settings without the need for sterilization between uses.

• What regulatory pathway was followed for the FDA clearance of the Bio-Pen Calculator, and when was it approved?

  The Bio-Pen Calculator received FDA clearance through a traditional 510(k) process, classified under product code LQB for Medical Computers and Software for Ophthalmic Use. The device was determined to be *substantially equivalent* to a predicate, and clearance was granted on April 24, 1986, following submission on January 22, 1986.

• Does the Bio-Pen Calculator require any special storage conditions, and is it safe for use in environments with MRI equipment?

  The provided data does not mention any specific storage conditions for the Bio-Pen Calculator, such as temperature or environmental requirements. Additionally, there is no indication of MRI safety (e.g., whether it is MRI-compatible or contains ferromagnetic materials), so caution should be exercised if used near MRI equipment.