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
K780189Substantially Equivalent

Platelet Rotator

Travenol Laboratories, S.A., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K780189 is the FDA 510(k) clearance record for PLATELET ROTATOR, a class I device, cleared for Travenol Laboratories, S.A. on under FDA product code KSQ (Device, Blood Mixing And Blood Weighing). FDA records list 206 510(k) clearances for Travenol Laboratories, S.A., from to . As of , FDA records show no recalls naming K780189.

Clearance record

Decision date
Received
(52 days to decision)
Product code
KSQ Device, Blood Mixing And Blood Weighing
Regulation
21 CFR 864.9195
Device class
Class I
Review panel
Hematology
Applicant
Travenol Laboratories, S.A. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code KSQ

Trailing 12 months

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

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