HANAULUX BLUE 30 & 80— 510(k) K954169

Clearance details

Applicant

Heraeus Med GmbH

Product code

Code FSY

Device class

Class 2

Regulation

21 CFR 878.4580

Advisory panel

General, Plastic Surgery

Date received

1995-09-05

Decision date

1996-02-01

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Hanau, DE

• K142984 — Leo Minor2014-10-29
• K142076 — CLAVEGUARD FREEDOM SURGICAL LIGHT2014-09-30
• K140812 — MI-750 PROCEDURAL/MINOR SURGICAL LIGHT2014-08-07
• K132551 — ZF 7202014-06-30
• K140930 — VIDA LED SURGICAL LIGHTING SYSTEM, V SERIES2014-06-09

• K973466 — HANAULUX BLUE 75 AND HANAULUX BLUE 1201997-10-24
• K970886 — HANAULUX BLUE 80 HOSPITAL1997-04-16

Malfunction

2,759

Other

1

Total

2,760

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 →

• Z-0770-2024 — Maquet Blueline Series 30/80 OR Light Systems, Model Numbers and Catalog Numbers BLUE 30 - ARD569015111A, BLUE 30 - ARD569015111C, BLUE 30 - ARD569015131C, BLUE 30 - ARD569025111C, BLUE 30 - ARD569025131C, BLUE 30 - ARD569035111C, BLUE 30 - ARD569035131C, BLUE 30 - ARD569045111C, BLUE 30 - ARD569045131C, BLUE 30 - ARD569055111C, BLUE 30 - ARD569055131C, BLUE 30 - ARD569065112C, BLUE 30 - ARD569065132C, BLUE 30 C - ARDBLU209000C, BLUE 3030 - ARD569015411C, BLUE 3030 - ARD569015431C, BLUE 80 - ARD569014111A, BLUE 80 - ARD569014111C, BLUE 80 - ARD569014131C, BLUE 80 - ARD569064112C, BLUE 80 - ARD569064132C, BLUE 8030 - ARD569014411C, BLUE 8030 - ARD569014431C, BLUE 8080 - ARD569014211C, BLUE 8080 - ARD569014231C, BLUE 30 - ARD569065113C, BLUE 30 - ARD569065123C, BLUE 30 - ARD569075113A, BLUE 30 - ARD569075113C, BLUE 30 - ARD569075123C, BLUE 80 - ARD569064113C, BLUE 80 - ARD569064123C, BLUE 80 - ARD569074113A, BLUE 80 - ARD569074113C, BLUE 80 - ARD569074123C, HLX BLUE 3 - ARD569132113AClass II·Ongoing·Getinge Usa Sales Inc·20231108

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K954169.