510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K010747Substantially Equivalent

Opc Oxygen Conserving Regulator, Model Ahg 1968, Lin-7005, Mdl-7609, Mem-7612, Opc-830

Western Ent., Westlake OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K010747 is the FDA 510(k) clearance record for OPC OXYGEN CONSERVING REGULATOR, MODEL AHG 1968, LIN-7005, MDL-7609, MEM-7612, OPC-830, a class II device, cleared for Western Ent. on under FDA product code NFB (Conserver, Oxygen). FDA records list one 510(k) clearance for Western Ent. As of , FDA records show 3 recalls naming K010747.

Clearance record

Decision date
Received
(64 days to decision)
Product code
NFB Conserver, Oxygen
Regulation
21 CFR 868.5905
Device class
Class II
Review panel
Anesthesiology
Applicant
Western Ent. 875 Bassett Rd., Westlake OH
510(k) summary
Summary
Third party review
No

Clearances, product code NFB

Trailing 12 months

FDA records hold no clearances under product code NFB in the trailing twelve months.

FDA records show no clearances under product code NFB in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NFB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260