510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K860848Substantially Equivalent

Vital Flow Nasal CPAP System

Systems 2000, Inc., Riverside CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K860848 is the FDA 510(k) clearance record for VITAL FLOW NASAL CPAP SYSTEM, a class II device, cleared for Systems 2000, Inc. on under FDA product code BYE (Attachment, Breathing, Positive End Expiratory Pressure). FDA records list one 510(k) clearance for Systems 2000, Inc. As of , FDA records show no recalls naming K860848.

Clearance record

Decision date
Received
(98 days to decision)
Product code
BYE Attachment, Breathing, Positive End Expiratory Pressure
Regulation
21 CFR 868.5965
Device class
Class II
Review panel
Anesthesiology
Applicant
Systems 2000, Inc. Attorney At Law, Riverside CA
Third party review
No

Clearances, product code BYE

Trailing 12 months

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

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