510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K980951Substantially Equivalent

Oneflow

Sti Medical, Cedar Grove NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K980951 is the FDA 510(k) clearance record for ONEFLOW, a class II device, cleared for Sti Medical on under FDA product code BZH (Meter, Peak Flow, Spirometry). FDA records list one 510(k) clearance for Sti Medical. As of , FDA records show no recalls naming K980951.

Clearance record

Decision date
Received
(714 days to decision)
Product code
BZH Meter, Peak Flow, Spirometry
Regulation
21 CFR 868.1860
Device class
Class II
Review panel
Anesthesiology
Applicant
Sti Medical 908 Pompton Ave., Cedar Grove NJ
510(k) summary
Statement
Third party review
No

Clearances, product code BZH

Trailing 12 months
2 clearances under product code BZH in the twelve months to October 2026, May 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code BZH, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20261
July 20260
August 20260
September 20260
October 20260