Medline ComfortTemp Patient Warming System— 510(k) K231211
Substantially EquivalentMedline Industries, LP
FDA 510(k) clearance K231211 for Medline ComfortTemp Patient Warming System, Substantially Equivalent on 2023-12-01. Applicant: Medline Industries, LP. Device class: 2.
Clearance details
- Applicant
- Medline Industries, LP
- Product code
- Code DWJ
- Device class
- Class 2
- Regulation
- 21 CFR 870.5900
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Northfield, IL, US
Recent devices under product code DWJ
view allMore clearances from Medline Industries, LP
view all- K253526 — NAMIC Dilator and Sheath
- K254287 — Medline Reusable Blood Pressure Cuff
- K253322 — Hudson RCI® Infant Dri-TechTM Breathing Circuits (HUD99060 / Dri-Tech with 78 Infant Circuit, HUD99060KIT / Dri-Tech with 78 Infant Circuit Kit, HUD99001KIT / Single Limb Infant Circuit Dri-Tech Kit, HUD99009KIT / Dri-Tech with 60 Infant Circuit Kit, HUD99018KIT / Dri-Tech with 44 Infant Circuit Kit, HUD870NKIT / Dri-Tech Infant Accessory Bag, HUD1631 / Infant Wye Connector with Swivel)
- K251687 — Konig Bell Circumcision Clamp
- K253070 — Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRADBANDL)
Adverse events under product code DWJ
product code DWJ- Death
- 7
- Injury
- 679
- Malfunction
- 17,477
- Total
- 18,163
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.