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
K800213Substantially Equivalent

Pharmacy Additive Syringe Set

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

K800213 is the FDA 510(k) clearance record for PHARMACY ADDITIVE SYRINGE SET, a class I device, cleared for Cutter Laboratories, Inc. on under FDA product code KYW (Container, Liquid Medication, Graduated). FDA records list 39 510(k) clearances for Cutter Laboratories, Inc., from to . As of , FDA records show no recalls naming K800213.

Clearance record

Decision date
Received
(25 days to decision)
Product code
KYW Container, Liquid Medication, Graduated
Regulation
21 CFR 880.6430
Device class
Class I
Review panel
General Hospital
Applicant
Cutter Laboratories, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code KYW

Trailing 12 months

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

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