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Pediarity

by Hinlab, Inc.

510(k) K231531

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK231531 Date21 Dec 2023ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 25 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  • Withdrawn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
DQA
Device Class
Class II
Regulation
21 CFR Part 870.2700
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

Pediarity is a medical device classified under product code DQA, which is intended for cardiovascular applications. The device has been determined to be substantially equivalent to predicate devices through the FDA's 510(k) clearance process.

Pediarity is manufactured by Hinlab, Inc. in Lewes, DE, and received FDA clearance on December 21, 2023, with K number K231531. The device is reviewed under the cardiovascular advisory committee and is supplied in various sizes as specified by the manufacturer.

Other devices from Hinlab Sas

  • Hinscope

    Class II

Questions

AI-generated answers, 1 Oct 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 Pediarity device used for?

    Pediarity is a medical device intended for cardiovascular applications. It is classified under product code DQA and has been determined to be substantially equivalent to predicate devices through the FDA's 510(k) clearance process.

  • How is the Pediarity device supplied?

    The Pediarity device is supplied in various sizes as specified by the manufacturer, Hinlab, Inc. The specific size options would be detailed in the product documentation provided by the manufacturer.

  • What is the regulatory status of the Pediarity device?

    The Pediarity device received FDA clearance on December 21, 2023, with K number K231531. It is classified under product code DQA and was reviewed under the cardiovascular advisory committee.

  • Who manufactures the Pediarity device?

    The Pediarity device is manufactured by Hinlab, Inc., located at 412 Canary Ct., Lewes, DE 19958. The contact person is Denys-Michel de Larouziere.