ROLL-A-WAY SHARPS DISPOSAL SYSTEM (RED AND IVORY)— 510(k) K943740

Clearance details

Applicant

Premium Plastics, Inc.

Product code

Code FMI

Device class

Class 2

Regulation

21 CFR 880.5570

Advisory panel

General Hospital

Date received

1994-08-02

Decision date

1994-12-14

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Chicago, IL, US

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

• K953226 — PULM O2 SUCTION CATHETER TRAYS1995-08-08
• K950851 — GENT-L-KARE TRACHEOSTOMY TRAYS1995-06-21
• K950850 — GENT-L-KARE LACERATION TRAYS1995-03-14
• K890107 — GENT-L-KARE(TM) STERILE, PRESSURE SORE MANAGE KIT1989-10-24
• K893135 — GENT-L-KARE STER SUCT CATH TRAY W/14 FR/STER WATER1989-06-22

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 →