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510(k) K242769

VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031) by Draegerwerk AG & CO Kgaa — Product Code BTL

K242769 is an FDA 510(k) premarket notification submitted by Draegerwerk AG & CO Kgaa for the device "VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031)". The FDA issued a decision of Substantially Equivalent on April 4, 2025. The device falls under product code BTL (Ventilator, Emergency, Powered (Resuscitator)), a Class II device regulated under 21 CFR 868.5925. Draegerwerk AG & CO Kgaa has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 4, 2025
Date Received
September 13, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Emergency, Powered (Resuscitator)
Device Class
Class II
Regulation Number
868.5925
Review Panel
AN
Submission Type

Other clearances by Draegerwerk AG & CO Kgaa

  • K253647 — Evita (V800); Evita (V600) (May 7, 2026)
  • K222822 — VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (M (June 14, 2023)
  • K222024 — Evita V800, Evita V600 (May 16, 2023)
  • K222207 — Babylog VN800, Babylog VN600 (May 16, 2023)
  • K221118 — CO2 Mainstream Sensor (April 5, 2023)
  • K162821 — Babyleo TN500 (June 23, 2017)
  • K093633 — INFINITY ACUTE CARE SYSTEM WORKSTATION CRITICAL CARE (March 30, 2010)

Other clearances for product code BTL

  • K221634 — Oxymag - Transport and Emergency Ventilator (May 24, 2023)
  • K202219 — VORTRAN GO2VENT with PEEP Valve (February 11, 2021)
  • K193191 — MEDUMAT Easy CPR, MEDUMAT Easy CPR with bag (November 20, 2020)
  • K182956 — Puffin Lite Infant Resuscitation System (January 18, 2019)
  • K173373 — SafeT T-Piece Resuscitator (November 16, 2018)
  • K161420 — MOVES SLC (June 6, 2017)
  • K162968 — VORTRAN GO2VENT (April 10, 2017)
  • K141595 — O-TWO E700,O-TWO E600,O-TWO E500 (March 16, 2015)
  • K142096 — T-PIECE RESUSCITATOR (October 17, 2014)
  • K140049 — MOVES SLC (May 29, 2014)

FDA data resources