510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K896526Substantially Equivalent

Lytening(tm) 5, Lytening(tm) System 30

Baxter Healthcare Corporation, Santa Ana CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K896526 is the FDA 510(k) clearance record for LYTENING(TM) 5, LYTENING(TM) SYSTEM 30, a class II device, cleared for Baxter Healthcare Corp on under FDA product code JGS (Electrode, Ion Specific, Sodium). FDA records list 570 510(k) clearances for Baxter Healthcare Corp, from to . As of , FDA records show no recalls naming K896526.

Clearance record

Decision date
Received
(50 days to decision)
Product code
JGS Electrode, Ion Specific, Sodium
Regulation
21 CFR 862.1665
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Baxter Healthcare Corp P.O. Box 25101, Santa Ana CA
Third party review
No

Clearances, product code JGS

Trailing 12 months
1 clearance under product code JGS in the twelve months to November 2026, May 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code JGS, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260