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PSA Series External Pulse-Generator Pacemaker

FDA 510(k)

Class II (US FDA 510(k))

510(k) K123916

by Osypka Medical, Inc.

Identifiers

510(k) Number
K123916 FDA 510(k)
FDA Product Code
DTE FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.3600 FDA 510(k)
Regulation Number
870.3600 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESK Substantially Equivalent — Kit FDA 510(k)

The PSA Series is an External Pulse-Generator Pacemaker, classified under product code DTE as a Class II device under FDA regulations. Designed for temporary cardiac pacing, it delivers electrical impulses to regulate heart rhythm in patients requiring short-term pacing support. This device is intended for use in clinical settings where immediate pacing intervention is necessary, such as post-cardiac surgery or acute bradycardia episodes. Its external configuration allows for easy application and monitoring without surgical implantation.

The PSA Series is supplied as a reusable medical device, intended for use in hospital or emergency settings where temporary pacing is required. It operates under sterile conditions when applied to patients and is regulated under FDA 510(k) clearance (K123916), with a decision date of April 9, 2013. The device adheres to 21 CFR 870.3600 and is reviewed under the Cardiovascular (CV) Advisory Committee. Multiple registration numbers (e.g., 3015225571, 3016678045) correspond to its various model variants, all falling under the same regulatory classification.

Frequently asked questions

What is the PSA Series External Pulse-Generator Pacemaker used for?

The PSA Series is designed for temporary cardiac pacing in clinical settings where immediate pacing intervention is required. This includes situations like acute bradycardia episodes or post-cardiac surgery, where patients need short-term regulation of their heart rhythm without surgical implantation. Its external configuration allows for easy application and monitoring.

Is the PSA Series a single-use or reusable device?

The PSA Series is supplied as a reusable medical device. It is intended for use in hospital or emergency settings where temporary pacing is required, allowing for repeated use across multiple patients under sterile conditions when applied.

What regulatory approval does the PSA Series hold?

The PSA Series is cleared by the FDA under the 510(k) pathway with clearance number K123916, dated April 9, 2013. It falls under product code DTE and adheres to 21 CFR 870.3600, with review by the Cardiovascular Advisory Committee. This classification ensures it meets regulatory standards for external pulse-generator pacemakers.

How is sterility maintained when using the PSA Series?

The PSA Series is intended to be used under sterile conditions when applied to patients. While the device itself is reusable, proper sterilization protocols must be followed between uses to ensure patient safety and compliance with medical standards.

What are the key model or registration numbers for the PSA Series?

The PSA Series includes multiple registration numbers corresponding to its model variants, such as 3015225571, 3016678045, and others like 3004593495, 3012536737, and 3018094310. These identifiers help distinguish specific variants while maintaining the same regulatory classification and intended use.

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: Osypka Medical, Inc. FDA 510 (k) Products (2002-2013), K123916 FDA 510 (k) - PSA SERIES | Osypka Medical, Inc., Temporary Cardiac Pacing - Osypka Medical, Medical Device Technology - OSYPKA

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Osypka Medical, Inc.

Sources (1)

  • FDA 510(k) K123916 24 fields · synced Oct 1, 2026