FDA 510(k)

Medline ComfortTemp Patient Warming System

K-Number: K231211 · 2023-12-01

Decision Date2023-12-01

Product CodeDWJ

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Medline ComfortTemp Patient Warming System is a medical device manufactured by Medline Industries, LP. It received FDA 510(k) clearance on 2023-12-01 under approval number K231211. The device is classified under product code DWJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Medline ComfortTemp Patient Warming System?

Medline ComfortTemp Patient Warming System is a medical device that received FDA 510(k) clearance on 2023-12-01. It is manufactured by Medline Industries, LP. The 510(k) number is K231211.

When was Medline ComfortTemp Patient Warming System approved by the FDA?

Medline ComfortTemp Patient Warming System received FDA 510(k) clearance on 2023-12-01, under approval number K231211.

What company makes Medline ComfortTemp Patient Warming System?

Medline ComfortTemp Patient Warming System is manufactured by Medline Industries, LP.

What is the FDA product code for Medline ComfortTemp Patient Warming System?

The FDA product code for Medline ComfortTemp Patient Warming System is DWJ.

Related Clinical Trials

NCT06011187 Assisted Fluid Management (AFM) System and Postoperative Outcome After High-risk Abdominal Surgery COMPLETED NCT07301385 Evaluation of Head-Mounted Spatial Computing and Three-Dimensional (3D) Visualization in Ocular Microsurgery: A Safety and Workflow Study ACTIVE_NOT_RECRUITING NCT03280862 DANISH-CRT - Does Electric Targeted LV Lead Positioning Improve Outcome in Patients With Heart Failure and Prolonged QRS COMPLETED NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT07039942 French Prospective Multicentric Study in Real World RECRUITING NCT04414280 The Impact of Hybrid Closed-loop Insulin Delivery in Type 1 Diabetes on Glycemic Control and PROMs ACTIVE_NOT_RECRUITING

Related PubMed Literature

PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025) PMID: 39977258 Priorities for medical device regulatory approval: a report from the European Society of Cardiology Cardiovascular Round Table. European heart journal (2025) PMID: 38815918 What is the MAUDE Database Telling us about 510(k) Authorization? Evaluation of Two Generations of Endovascular Arteriovenous Fistula Devices. Annals of vascular surgery (2024) PMID: 38767890 Strengthening the use of artificial intelligence within healthcare delivery organizations: balancing regulatory compliance and patient safety. Journal of the American Medical Informatics Association : JAMIA (2024)

Other Devices by Medline Industries, LP

K220365Gemini Sterilization Wrap K221360Medline UNITE® Medial Malleolus Peg Plate System K220333Medline Orbis LVL 3 Surgical Gown K214108Medline Orbis Chemo Surgical Gown K220511Medline UNITE IM Fibula Implant K213567Medline UNITE Calcaneal Fracture Plating System

View all 29 devices →

Related Devices (Code: DWJ)

K152266Altrix Precision Temperature Management SystemStryker Medical K161602Arctic Sun Temperature Management SystemMedivance, Inc. K1713733M Bair Hugger Model 675 Total Temperature Management System3M Company K171149Altrix Temperature Management WrapsStryker Medical K171234Mistral-Air Warming UnitThe Surgical Company International BV (As the 37company) K162679IOB Temperature Management SystemIob Medical, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.