Home / 510(k) Clearances / K240561

510(k) K240561

Rugged Oxygen Generator (ROG) (RO01-00001) by Molecular Products , Ltd. — Product Code CAW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 6, 2024
Date Received
February 29, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Generator, Oxygen, Portable
Device Class
Class II
Regulation Number
868.5440
Review Panel
AN
Submission Type

Other clearances by Molecular Products , Ltd.

  • K131016 — ROGS (November 27, 2013)
  • K062153 — PORTABLE OXYGEN GENERATOR SYSTEM (November 21, 2006)
  • K921803 — SOFNOLIME CARBON DIOXIDE ABSORBENT (October 15, 1992)

Other clearances for product code CAW

  • K251534 — Oxygen Concentrator (J10A) (December 29, 2025)
  • K251764 — Oxygen Concentrator-P2-O5E (December 22, 2025)
  • K252616 — Portable oxygen concentrator (JLO-190P) (December 22, 2025)
  • K252268 — V series portable oxygen concentrator (V5, V5C, V6, V6C) (December 16, 2025)
  • K250805 — DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW) (December 9, 2025)
  • K251607 — Oxygen Concentrator (J5A) (November 21, 2025)
  • K243833 — Portable oxygen concentrator (JAY-1000P) (September 29, 2025)
  • K250625 — Portable oxygen concentrator (W-R1(MAX)); Portable oxygen concentrator (W-R1); (August 27, 2025)
  • K251130 — Portable Oxygen Concentrator (JM-P50A) (August 21, 2025)
  • K250671 — FreeStyle Comfort (AS200 / FreeStyle Comfort) (July 11, 2025)