Home / 510(k) Clearances / K220591

510(k) K220591

Proxima by Dynasthetics, LLC — Product Code NFB

K220591 is an FDA 510(k) premarket notification submitted by Dynasthetics, LLC for the device "Proxima". The FDA issued a decision of Substantially Equivalent on December 15, 2022. The device falls under product code NFB (Conserver, Oxygen), a Class II device regulated under 21 CFR 868.5905.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 2022
Date Received
March 1, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Conserver, Oxygen
Device Class
Class II
Regulation Number
868.5905
Review Panel
AN
Submission Type

Other clearances for product code NFB

  • K250322 — Respond OC Conserving Regulator (130-0800) (July 24, 2025)
  • K221014 — Effortless Oxygen Conserver System Models Effortless Pro and Effortless Mobile (October 17, 2022)
  • K200401 — Apogee (November 14, 2020)
  • K151506 — Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen Cannula (March 11, 2016)
  • K131023 — THERAFLOW SINGLE LUMEN AND THERAFLOW DUAL LUMEN (October 11, 2013)
  • K113111 — CHAD THERAPEUTIC EVOLUTION ELECTRONIC OXYGEN CONSERVER WITH MOTION (December 8, 2011)
  • K103392 — CHAD THERAPEUTIC EVOLUTION ELECTRONIC OXYGEN CONSERVER (December 17, 2010)
  • K090421 — MODEL 350G GAS CONSERVER (May 29, 2009)
  • K070740 — CHAD THERAPEUTICS BONSAI MODEL 800 (May 7, 2007)
  • K060751 — INOVO, INC. ACCUPULSE SINGLE LUMEN CONSERVING REGULATOR (July 18, 2006)

FDA data resources