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Hanaulux Blue 80 Hospital

by Heraeus Med GmbH

510(k) K970886

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

Recall on shared 510(k) K970886; other models may be affected

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK970886 Date16 Apr 1997ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-0770-2024 FDA Class II initiated 8 Nov 2023 on shared 510(k) K970886

    A potential for a light system to fall in the operating room.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
FSS
Device Class
Class II
Regulation
21 CFR Part 878.4580
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Hanaulux Blue 80 Hospital is a floor‑standing surgical illumination device classified as a Light, Surgical, Floor Standing. It provides high‑intensity, adjustable lighting for use in operating rooms and other clinical settings where precise visualisation is required.

The device is marketed by Heraeus Med GmbH and received FDA 510(k) clearance (decision date 1997‑04‑16, decision code SESE) under product code FSS as a Class II device with special controls. It is supplied as a single, reusable unit; no sterility or single‑use claims are indicated. The device is identified by K‑number K970886 and is intended for general and plastic surgery applications.

Other devices from Heraeus Med GmbH

Questions

AI-generated answers, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the HANAULUX BLUE 80 HOSPITAL used for?

    It is a floor-standing surgical illumination device designed for high-intensity, adjustable lighting in operating rooms and clinical settings where precise visualisation is required, particularly in general and plastic surgery.

  • Is the HANAULUX BLUE 80 HOSPITAL supplied as sterile or single-use?

    No, the device is supplied as a single, reusable unit. The available data does not indicate any sterility claims or single-use design; it is intended for repeated clinical use with appropriate cleaning and maintenance.

  • What regulatory clearance does the HANAULUX BLUE 80 HOSPITAL have?

    It received FDA 510(k) clearance on 1997-04-16 under K-number K970886, classified as a Class II device with product code FSS. The decision code was SESE, indicating substantial equivalence to a predicate device.

  • Who manufactures the HANAULUX BLUE 80 HOSPITAL and where is it based?

    The device is manufactured by Heraeus Med GmbH, located at Heraeusstrasse 12-14, D-63450 Hanau, Germany. The applicant listed on the clearance is Heraeus Med GmbH.