510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K051988Substantially Equivalent

Oxy-Serve II Oxygen Conserving Regulator

Superior Products, LLC, Cleveland OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K051988 is the FDA 510(k) clearance record for OXY-SERVE II OXYGEN CONSERVING REGULATOR, a class II device, cleared for Superior Products, Inc. on under FDA product code NFB (Conserver, Oxygen). FDA records list one 510(k) clearance for Superior Products, Inc. As of , FDA records show one recall naming K051988.

Clearance record

Decision date
Received
(61 days to decision)
Product code
NFB Conserver, Oxygen
Regulation
21 CFR 868.5905
Device class
Class II
Review panel
Anesthesiology
Applicant
Superior Products, Inc. 3786 Ridge Rd., Cleveland OH
510(k) summary
Summary PDF
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