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
K861861Substantially Equivalent

515A Neo-Trak Neonatal Monitor

GE Medical Systems Information Technologies, Inc., Wallingford CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K861861 is the FDA 510(k) clearance record for 515A NEO-TRAK NEONATAL MONITOR, a class II device, cleared for Ge Medical Systems Information Technologies on under FDA product code KLK (Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia). FDA records list 171 510(k) clearances for Ge Medical Systems Information Technologies, from to . As of , FDA records show no recalls naming K861861.

Clearance record

Decision date
Received
(57 days to decision)
Product code
KLK Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
Regulation
21 CFR 868.2500
Device class
Class II
Review panel
Anesthesiology
Applicant
Ge Medical Systems Information Technologies 61 Barnes Park Rd. N., Wallingford CT
Third party review
No

Clearances, product code KLK

Trailing 12 months

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

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