Home / 510(k) Clearances / K101130

510(k) K101130

BIPAP SYNCHRONY 2 WITH AF531 FULL FACE MASK by Respironics, Inc. — Product Code MNS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 2, 2010
Date Received
April 22, 2010
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Continuous, Non-Life-Supporting
Device Class
Class II
Regulation Number
868.5895
Review Panel
AN
Submission Type

Other clearances by Respironics, Inc.

  • K243394 — AF531 Oro-Nasal SE Face Mask (December 30, 2024)
  • K231313 — Therapy Mask 3100 NC/SP (July 28, 2023)
  • K210844 — DreamWear Silicone Pillows Mask (August 24, 2021)
  • K210386 — Magneto Nasal Mask (July 12, 2021)
  • K202142 — Sleepware G3 (October 29, 2020)
  • K201439 — Ventilator, Non-continuous (Respirator) (September 25, 2020)
  • K200480 — DreamStation 2 System, DreamStation 2 Advanced System (July 10, 2020)
  • K183226 — Care Orchestrator Essence (October 18, 2019)
  • K183625 — SomnaPatch (October 18, 2019)
  • K181170 — Trilogy Evo Universal (July 18, 2019)

Other clearances for product code MNS

  • K251661 — Mariana Minerva; Mariana Nimbus (February 23, 2026)
  • K240778 — Vivo 1, Vivo 2 (December 13, 2024)
  • K231064 — ReddyPort Elbow (July 13, 2023)
  • K213169 — BPAP System (December 5, 2022)
  • K171827 — ReddyPort NIV Access Elbow (January 19, 2018)
  • K161492 — Juno VPAP ST-A (January 19, 2017)
  • K161487 — VPAP Adapt SV, VPAP Tx, S9 VPAP Tx (September 9, 2016)
  • K153061 — Juno VPAP ST-A (April 13, 2016)
  • K132371 — EASYCARE ONLINE (November 22, 2013)
  • K123511 — S9 VPAP TX (March 21, 2013)