510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K970371Substantially Equivalent

Flotec Oxysavrr (S)

Flotec, Inc., Indianapolis IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K970371 is the FDA 510(k) clearance record for FLOTEC OXYSAVRR (S), a class II device, cleared for Flotec, Inc. on under FDA product code NFB (Conserver, Oxygen). FDA records list 2 510(k) clearances for Flotec, Inc., from to . As of , FDA records show no recalls naming K970371.

Clearance record

Decision date
Received
(160 days to decision)
Product code
NFB Conserver, Oxygen
Regulation
21 CFR 868.5905
Device class
Class II
Review panel
Anesthesiology
Applicant
Flotec, Inc. 8132 Woodland Dr., Indianapolis IN
510(k) summary
Statement
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