510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K943829Substantially Equivalent

Pre-Filled Sysringe W/sterile Water

Orion Life Systems, Inc., Palm Harbor FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K943829 is the FDA 510(k) clearance record for PRE-FILLED SYSRINGE W/STERILE WATER, a class II device, cleared for Orion Life Systems, Inc. on under FDA product code JOL (Catheter And Tip, Suction). FDA records list 33 510(k) clearances for Orion Life Systems, Inc., from to . As of , FDA records show no recalls naming K943829.

Clearance record

Decision date
Received
(108 days to decision)
Product code
JOL Catheter And Tip, Suction
Regulation
21 CFR 880.6740
Device class
Class II
Review panel
General Hospital
Applicant
Orion Life Systems, Inc. P.O. Box 2308, Palm Harbor FL
510(k) summary
Statement
Third party review
No

Clearances, product code JOL

Trailing 12 months

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

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