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
K801899Substantially Equivalent

Keithley Lymphocyte Depletion Cart

Keithley Development Co., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K801899 is the FDA 510(k) clearance record for KEITHLEY LYMPHOCYTE DEPLETION CART, a class II device, cleared for Keithley Development Co. on under FDA product code KDK (Container, Transport, Kidney). FDA records list 2 510(k) clearances for Keithley Development Co., from to . As of , FDA records show no recalls naming K801899.

Clearance record

Decision date
Received
(49 days to decision)
Product code
KDK Container, Transport, Kidney
Regulation
21 CFR 876.5880
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Keithley Development Co. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code KDK

Trailing 12 months

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

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