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Celsi Monitor

by Hadleigh Health Technologies

510(k) K230298

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 NumberK230298 Date16 Aug 2023ClearedStatusActive

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  • Withdrawn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
FLL
Device Class
Class II
Regulation
21 CFR Part 880.2910
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 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 Celsi Monitor is a continuous measurement thermometer designed for newborn temperature monitoring. It continuously monitors an infant's temperature, providing real-time alerts to help healthcare professionals quickly identify hypothermia and hyperthermia before complications occur. This device is intended for use in neonatal units, NICUs, and low-resource healthcare settings.

The Celsi Monitor is supplied by Hadleigh Health Technologies and is classified as a Class II device with special controls under product code FLL. It received FDA 510(k) clearance on August 16, 2023, after a review cycle of 195 days. The device is designed for clinical-grade use in healthcare settings for continuous newborn temperature monitoring.

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