BLOOD COLLECTION TUBE HOLDER VANISHPOINT TUBE HOLDER/SMALL TUBE ADAPTER— 510(k) K971763

Clearance details

Applicant

Retractable Technologies, Inc.

Product code

Code FMI

Device class

Class 2

Regulation

21 CFR 880.5570

Advisory panel

General Hospital

Date received

1997-05-13

Decision date

1997-08-26

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Little Elm, TX, US

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

• K202325 — EasyPoint Blood Collection Plus2021-04-09
• K133635 — EASYPOINT NEEDLE2014-06-17
• K122355 — VANISHPOINT BLOOD COLLECTION SET2013-08-23
• K112512 — VANISHPOINT BLOOD COLLECTION SET2011-10-20
• K101708 — PATIENT SAFE LUER CAP2011-02-24

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 →