510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K900439Substantially Equivalent

Single-Use, Sterile, Prefilled Syringe, 60Cc

L H M Ent., Inc., Indian Mills NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K900439 is the FDA 510(k) clearance record for SINGLE-USE, STERILE, PREFILLED SYRINGE, 60CC, a class II device, cleared for L H M Ent., Inc. on under FDA product code FIH (Pump, Infusion Or Syringe, Extra-Luminal). FDA records list 6 510(k) clearances for L H M Ent., Inc., from to . As of , FDA records show no recalls naming K900439.

Clearance record

Decision date
Received
(17 days to decision)
Product code
FIH Pump, Infusion Or Syringe, Extra-Luminal
Regulation
21 CFR 876.5820
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
L H M Ent., Inc. 237 Dingletown Rd., Indian Mills NJ
Third party review
No

Clearances, product code FIH

Trailing 12 months

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

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