Cleared Traditional

Level 1 Convective Warmer

K181699 · Smiths Medical Asd, Inc. · Cardiovascular

Jul 2018

Decision

29d

Days

Class 2

Risk

About This 510(k) Submission

K181699 is an FDA 510(k) clearance for the Level 1 Convective Warmer, a System, Thermal Regulating (Class II — Special Controls, product code DWJ), submitted by Smiths Medical Asd, Inc. (Minnepolis, US). The FDA issued a Cleared decision on July 26, 2018, 29 days after receiving the submission on June 27, 2018. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5900.

Submission Details

510(k) Number	K181699 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 27, 2018
Decision Date	July 26, 2018
Days to Decision	29 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	DWJ — System, Thermal Regulating
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.5900
Definition	If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).