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Bio-Pen SRK II Calculator

FDA 510(k)

Class III (US FDA 510(k))

510(k) K922590

by Bio-Rad

Identifiers

510(k) Number
K922590 FDA 510(k)
FDA Product Code
LQB FDA 510(k)

Classification

Device Class
Class III FDA 510(k)
Advisory Committee
Unknown FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Bio-Pen SRK II Calculator is a medical computer and software system designed for ophthalmic use. It performs calculations related to refractive surgery, specifically for the SRK (Schiottz Regression Formula) II algorithm, aiding in intraocular lens power determination during cataract surgery planning.

This device is supplied as a standalone calculator and is intended for single-use in clinical settings. It does not require sterilisation and is classified as a Class III medical device under FDA regulations. The device is authorised through an FDA 510(k) clearance (K922590) and was determined to be substantially equivalent to a predicate device. No specific MRI safety information or size variations are noted in the available data.

Frequently asked questions

What is the primary clinical purpose of the Bio-Pen SRK II Calculator, and how does it assist in cataract surgery planning?

The Bio-Pen SRK II Calculator is specifically designed to perform calculations using the SRK II algorithm, which helps determine the appropriate power of intraocular lenses during cataract surgery planning. By providing precise refractive surgery calculations, it aids ophthalmologists in selecting the correct lens to optimize visual outcomes for patients.

Is the Bio-Pen SRK II Calculator reusable in a clinical setting, or is it intended for single-use?

The device is explicitly described as intended for single-use in clinical settings. Since it does not require sterilization, it is supplied as a standalone calculator meant to be discarded after one use, ensuring hygiene and compliance with medical device protocols.

How is the Bio-Pen SRK II Calculator authorized for use in the U.S., and what type of regulatory clearance does it hold?

The device holds an FDA 510(k) clearance (K922590), meaning it was determined to be substantially equivalent to a predicate device already on the market. This clearance was granted under the Traditional 510(k) review pathway, confirming its compliance with U.S. regulatory standards for medical computers and software used in ophthalmology.

Does the Bio-Pen SRK II Calculator come in different sizes or models, or is it supplied as a single standardized unit?

The available data does not mention any variations in size or model for the Bio-Pen SRK II Calculator. It is supplied as a standalone calculator without additional size or configuration options, making it a uniform tool for refractive surgery calculations.

Since the device is not sterilized, how should it be handled in a clinical environment to maintain proper hygiene?

Because the Bio-Pen SRK II Calculator is intended for single-use and does not require sterilization, clinical staff should follow standard medical device handling protocols: use it once per patient, then dispose of it properly in accordance with facility waste management guidelines. This ensures compliance with infection control measures without the need for sterilization.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: BIO-PEN SRK II CALCULATOR (K922590) — FDA 510(k) | Innolitics, Bio-pen Srk Ii Calculator 510 (k) K922590 - FDA.report, 510(k) Premarket Notification, fda.innolitics.com, Chromatography Conversion Calculators | Bio-Rad

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Bio-Rad

Sources (1)

  • FDA 510(k) K922590 24 fields · synced Sep 18, 2026