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Custo Vit Pulmonary Function Analysis System

by Versacor, Inc.

510(k) K854745

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK854745 Date10 Jan 1986ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
BTY
Device Class
Class II
Regulation
21 CFR Part 868.1890
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 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 Custo Vit Pulmonary Function Analysis System is a device used to calculate predicted pulmonary function values. It is classified as a calculator and is intended for use in pulmonary function analysis.

The device is supplied as a single-use system and is not reusable. It is not MRI safe and requires storage under standard conditions. The device has received FDA 510(k) clearance (K854745) and is regulated under regulation number 868.1890.

Other devices from Versacor, Inc.

Questions

AI-generated answers, 25 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 Custo Vit Pulmonary Function Analysis System used for?

    This device is a calculator used to calculate predicted pulmonary function values. It is intended for use in pulmonary function analysis.

  • Is the Custo Vit Pulmonary Function Analysis System reusable?

    No, the device is supplied as a single-use system and is not reusable.

  • What are the storage requirements for the Custo Vit Pulmonary Function Analysis System?

    The device requires storage under standard conditions.

  • What is the regulatory status of the Custo Vit Pulmonary Function Analysis System?

    The device has received FDA 510(k) clearance (K854745) and is regulated under regulation number 868.1890.