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Fluid Level Monitor

by Coleman Laboratories

510(k) K133870

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 NumberK133870 Date24 Apr 2014ClearedStatusActive

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  • Withdrawn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
FLN
Device Class
Class II
Regulation
21 CFR Part 880.2420
Advisory Committee
General Hospital
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 Fluid Level Monitor is a Class 2 device intended for low-fluid-level alarm use in healthcare settings where gravity flow infusion is utilized. It provides timely notification of the low-fluid-level status to healthcare personnel.

The device is manufactured by Coleman Laboratories and was cleared through the Traditional 510(k) pathway after a 125-day FDA review. It is authorized for use in general hospital settings and is designed to improve efficiency within busy medical environments.

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