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
K854155Substantially Equivalent

Sterile Saline Solution

I M, Inc., Fairfield NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K854155 is the FDA 510(k) clearance record for STERILE SALINE SOLUTION, a class I device, cleared for I M, Inc. on under FDA product code KMJ (Lubricant, Patient). FDA records list 15 510(k) clearances for I M, Inc., from to . As of , FDA records show no recalls naming K854155.

Clearance record

Decision date
Received
(60 days to decision)
Product code
KMJ Lubricant, Patient
Regulation
21 CFR 880.6375
Device class
Class I
Review panel
General Hospital
Applicant
I M, Inc. P.O. Box 658, Fairfield NJ
Third party review
No

Clearances, product code KMJ

Trailing 12 months

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

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