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VPC

by Pajunk GmbH Medizintechnologie

510(k) K190345

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK190345 Date16 May 2019ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
CAZ
Device class
Class II
Regulation
21 CFR Part 868.5140
Advisory committee
Anesthesiology
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The VPC is an Anesthesia Conduction Kit, a device used in anesthesiology for the identification of the epidural space. It provides a visual indication of loss of resistance during epidural procedures.

The VPC is supplied by PAJUNK GmbH Medizintechnologie and has received FDA 510(k) clearance (K190345) as a Class 2 device under product code CAZ. It was cleared via the traditional 510(k) pathway following a 91-day review and is substantially equivalent to a legally marketed device.

Other devices from Pajunk GmbH Medizintechnologie

See all devices from Pajunk GmbH Medizintechnologie →

Questions

AI-generated answers, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the VPC used for in anesthesiology?

    The VPC is an Anesthesia Conduction Kit used to identify the epidural space during epidural procedures by providing a visual indication of loss of resistance, which helps clinicians confirm proper needle placement.

  • Who manufactures the VPC and where is it supplied from?

    The VPC is manufactured and supplied by Pajunk GmbH Medizintechnologie, located at Karl-Hall-Str 1, Geisingen, DE 78187, Germany, as indicated in the device authorization data.

  • Is the VPC a single-use or reusable device, and what is its regulatory classification?

    The VPC is a Class 2 medical device under product code CAZ, cleared via FDA 510(k) pathway (K190345) as substantially equivalent to a legally marketed device; however, the provided data does not specify whether it is single-use or reusable, so reuse status cannot be confirmed from the given information.

  • What is the FDA 510(k) number and clearance pathway for the VPC?

    The VPC received FDA 510(k) clearance under number K190345 through the traditional 510(k) pathway, with a 91-day review period, and was determined to be substantially equivalent to a predicate device.

  • What product code and medical specialty is associated with the VPC under FDA regulations?

    The VPC is assigned FDA product code CAZ and is categorized under the medical specialty of Anesthesiology, as reflected in both the product_code and medical_specialty_description fields in the device data.