510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K883400Substantially Equivalent

Optum(tm) Automated Patient Assist Device

Abbott Medical, Abbott Park IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K883400 is the FDA 510(k) clearance record for OPTUM(TM) AUTOMATED PATIENT ASSIST DEVICE, a class II device, cleared for Abbott Laboratories on under FDA product code KPE (Container, I.V.). FDA records list 1,478 510(k) clearances for Abbott Medical, from to . As of , FDA records show no recalls naming K883400.

Clearance record

Decision date
Received
(476 days to decision)
Product code
KPE Container, I.V.
Regulation
21 CFR 880.5025
Device class
Class II
Review panel
General Hospital
Applicant
Abbott Laboratories One Abbott Park Rd., Abbott Park IL
Third party review
No

Clearances, product code KPE

Trailing 12 months
3 clearances under product code KPE in the twelve months to November 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KPE, trailing twelve months
MonthClearances
December 20250
January 20261
February 20260
March 20261
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260