510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K060382Substantially Equivalent

Flo-Rite, Model 478-1; Flo-Rite II, Model 478-1; Simpulse II, Model 478-2S; Numatix, Model Ncd401; Simpulse, Model 478-1

Ameriflo Corp., Carmel IN / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K060382 is the FDA 510(k) clearance record for FLO-RITE, MODEL 478-1; FLO-RITE II, MODEL 478-1; SIMPULSE II, MODEL 478-2S; NUMATIX, MODEL NCD401; SIMPULSE, MODEL 478-1, a class II device, cleared for Ameriflo Corp. on under FDA product code NFB (Conserver, Oxygen). FDA records list 2 510(k) clearances for Ameriflo Corp., from to . As of , FDA records show no recalls naming K060382.

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
Ameriflo Corp. 478 Gradle Dr., Carmel IN
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