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510(k) K132048

BARRIER EASYWARM ACTIVE SELF-WARMING BLANKET by Molnlycke Health Care Us, LLC — Product Code DWJ

K132048 is an FDA 510(k) premarket notification submitted by Molnlycke Health Care Us, LLC for the device "BARRIER EASYWARM ACTIVE SELF-WARMING BLANKET". The FDA issued a decision of Substantially Equivalent on November 6, 2013. The device falls under product code DWJ (System, Thermal Regulating), a Class II device regulated under 21 CFR 870.5900. Molnlycke Health Care Us, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 6, 2013
Date Received
July 2, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Thermal Regulating
Device Class
Class II
Regulation Number
870.5900
Review Panel
CV
Submission Type

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).

Other clearances by Molnlycke Health Care Us, LLC

  • K232508 — Barrier EasyWarm Active Self-Warming Blanket (September 15, 2023)
  • K203369 — Avance Solo Negative Pressure Wound Therapy (NPWT) System (July 1, 2021)
  • K202090 — Biogel Eclipse / Biogel Eclipse Indicator Underglove, Biogel Surgeons / Biogel I (November 22, 2020)
  • K193573 — Biogel Skinsense Indicator Underglove, Biogel PI Ultratouch, Biogel PI Indicator (April 10, 2020)
  • K191869 — Biogel(R) PI UltraTouch S Surgical Glove with a Low Dermatitis Potential Claim, (March 13, 2020)
  • K190077 — Biogel® PI UltraTouch S Surgical Glove, Biogel® Pl Ultra Touch S Indicator Under (May 24, 2019)
  • K161939 — Avance Abdominal Dressing Kit (November 17, 2016)
  • K161935 — Avance Foam Dressing Kit - XL (November 4, 2016)
  • K161948 — Avance Gauze Dressing Kits (November 3, 2016)
  • K161797 — Avance Tubing, Avance Y-Connector, Avance ViewPad (October 19, 2016)

Other clearances for product code DWJ

  • K262089 — Disposable Warming Blanket (August 21, 2026)
  • K261437 — Mistral-Air® Warming System (August 7, 2026)
  • K260278 — ThermAffyx(TM) Patient Safety System (July 8, 2026)
  • K260903 — Hot Pink Pad Warming System (April 16, 2026)
  • K252861 — Warming System (April 7, 2026)
  • K251974 — Arctic Sun Temperature Management System (Model 5000) (October 24, 2025)
  • K242964 — Celsi Warmer (June 20, 2025)
  • K243942 — Arctic Sun Stat Temperature Management System (April 30, 2025)
  • K232627 — HotDog Warming Mattress + Return Electrode (April 18, 2024)
  • K232502 — Cocoon Convective Warming System, Model CWS7000 (February 21, 2024)

FDA data resources