510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K834214Substantially Equivalent

Wescor 5500 Vapor Pressure Osmometer

ELITechGroup Inc, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K834214 is the FDA 510(k) clearance record for WESCOR 5500 VAPOR PRESSURE OSMOMETER, a class I device, cleared for Wescor, Inc. on under FDA product code JJM (Osmometer For Clinical Use). FDA records list 32 510(k) clearances for ELITechGroup Inc, from to . As of , FDA records show no recalls naming K834214.

Clearance record

Decision date
Received
(116 days to decision)
Product code
JJM Osmometer For Clinical Use
Regulation
21 CFR 862.2730
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Wescor, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code JJM

Trailing 12 months

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

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