KSWClass II

System, Processing For Frozen Blood

21 CFR 864.9145 / Hematology

KSW is the FDA product code for System, Processing For Frozen Blood, a class II device type, regulated under 21 CFR 864.9145. As of 2026-09-10, FDA records hold one 510(k) clearance under this code, the most recent dated 1976-11-23, and no recalls.

Classification record

Product code: KSW
Device name: System, Processing For Frozen Blood
Regulation: 21 CFR 864.9145
Device class: Class II
Review panel: Hematology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 1
Ingested recalls: 0

Clearances, product code KSW

By decision year

1 clearance under product code KSW with a decision year between 1976 and 1976, 1976 the highest year at 1.

Show the numbers

510(k) clearances under FDA product code KSW by decision year
Year	Clearances
1976	1

Applicants with the most clearances

Product code KSW

Applicants holding the most 510(k) clearances under product code KSW
Applicant	Clearances
Travenol Laboratories, S.A.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

Recent clearances

Product code KSW

K760914Class IIDouble Elutra-Pack UnitTravenol Laboratories, S.A. / cleared 1976-11-23

Recent recalls

Product code KSW

FDA records show no recalls under product code KSW.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)