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Vacu-Pro

by Concord/Portex

510(k) K922445

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 NumberK922445 Date12 Aug 1992ClearedStatusActive

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  • Withdrawn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
JKA
Device Class
Class II
Regulation
21 CFR Part 862.1675
Advisory Committee
Clinical Chemistry
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.

This device is a chemistry analyzer or related clinical chemistry instrument, as indicated by its product code JKA and advisory committee classification under Clinical Chemistry (CH). It was submitted for FDA review as a substantially equivalent device under the traditional 510(k) pathway.

The Vacu-Pro received FDA 510(k) clearance (K922445) on August 12, 1992, following submission on May 22, 1992. It is manufactured by Concord/Portex located in Keene, New Hampshire, and is identified by the device name Vacu-Pro and product code JKA.

Other devices from Concord/Portex

See all devices from Concord/Portex →

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 Vacu-Pro device used for?

    The Vacu-Pro is a chemistry analyzer or related clinical chemistry instrument, as indicated by its product code JKA and advisory committee classification under Clinical Chemistry (CH), designed for performing clinical chemistry tests.

  • Who manufactures the Vacu-Pro and where is it made?

    The Vacu-Pro is manufactured by Concord/Portex, located at 15 Kitt St., Keene, New Hampshire, 03431, United States, as specified in the device authorization records.

  • How was the Vacu-Pro cleared for market release?

    The Vacu-Pro received FDA 510(k) clearance through the traditional pathway as a substantially equivalent device, with clearance granted on August 12, 1992, under K-number K922445 following submission on May 22, 1992.