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KM - KAL 5

by Kmn Products, Inc.

510(k) K823021

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 NumberK823021 Date16 Nov 1982ClearedStatusActive

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  • Withdrawn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
JIT
Device Class
Class II
Regulation
21 CFR Part 862.1150
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 28 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 KM - KAL 5 is a secondary calibrator used in clinical chemistry. It is a device intended for calibration of laboratory instruments to ensure accurate measurement of analytes in clinical specimens.

The device is supplied as a non-sterile, reusable product for use in laboratory settings. It has received FDA 510(k) clearance under K823021 and is classified as a Class II medical device. Storage and handling should follow manufacturer guidelines, and it is not indicated for MRI safety or single-use application.

Other devices from Kmn Products, Inc.

  • Km-Kal L1

    Class II

  • Km-Kal 4

    Class II

  • Km-Kal 3

    Class II

  • Km-Kal L2

    Class II

  • Km-Kal L5

    Class II

  • Km - Kal 1

    Class II

See all devices from Kmn Products, Inc. →

Questions

AI-generated answers, 28 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 KM - KAL 5 used for?

    The KM - KAL 5 is a secondary calibrator intended for calibration of laboratory instruments to ensure accurate measurement of analytes in clinical specimens within clinical chemistry settings.

  • Is the KM - KAL 5 sterile or single-use?

    The KM - KAL 5 is supplied as a non-sterile, reusable product and is not indicated for single-use application; it is designed for repeated use in laboratory environments following manufacturer guidelines.

  • How is the KM - KAL 5 supplied and stored?

    The device is supplied as a non-sterile, reusable calibrator for laboratory use, and storage and handling should follow the manufacturer's guidelines to maintain performance and integrity.

  • What regulatory clearance does the KM - KAL 5 have?

    The KM - KAL 5 has received FDA 510(k) clearance under submission number K823021 and is classified as a Class II medical device under regulation number 862.1150.

  • What type of device is the KM - KAL 5 and what is its product code?

    The KM - KAL 5 is a secondary calibrator in the clinical chemistry specialty with product code JIT, as indicated in its FDA 510(k) submission and device listing.