510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K864789Substantially Equivalent

Betaflo 2000 Piggyback System

Betaflo, Inc., Menlo Park CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K864789 is the FDA 510(k) clearance record for BETAFLO 2000 PIGGYBACK SYSTEM, a class II device, cleared for Betaflo, Inc. on under FDA product code LDR (Controller, Infusion, Intravascular, Electronic). FDA records list 2 510(k) clearances for Betaflo, Inc., from to . As of , FDA records show no recalls naming K864789.

Clearance record

Decision date
Received
(58 days to decision)
Product code
LDR Controller, Infusion, Intravascular, Electronic
Regulation
21 CFR 880.5725
Device class
Class II
Review panel
General Hospital
Applicant
Betaflo, Inc. 1060 Marsh Rd., Menlo Park CA
Third party review
No

Clearances, product code LDR

Trailing 12 months

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

FDA records show no clearances under product code LDR in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LDR, 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