VACUUM TUBE HOLDER CULTURE MEDIUM VIAL HOLDER— 510(k) K935514

Clearance details

Applicant

Kawasumi Laboratories Co., Ltd.

Product code

Code FMI

Device class

Class 2

Regulation

21 CFR 880.5570

Advisory panel

General Hospital

Date received

1993-11-16

Decision date

1994-02-10

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Tokyo, JP

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• K261829 — Profoject Dual-Safety Pen Needles2026-07-29
• K260739 — Profoject Pen Needles (Model A; Model B)2026-07-15

• K994323 — KAWASUMI LABORATORIES PHILEBOTOMY SET2000-03-08
• K974829 — NON-PVC FLUID PATH PORT ACCESS INFUSION SET (WITH AND WITHOUT INJECTION SET)1998-02-12
• K964117 — NON-PVC FLUID PATH PORT ACCESS INFUSION SET WITH SLIT SEPTUM INJECTION SITE1997-03-14
• K935505 — WINGED COLLECTION SET W/MULTI-SAMPLE LUER ADAPTER1994-02-03
• K935506 — MULTI-SAMPLE LUER ADAPTER FOR BLOOD SAMPLE COLLECTION1994-02-03

Death

28

Injury

1,517

Malfunction

23,981

Other

18

Total

25,544

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →