Cleared Traditional

K970886 - HANAULUX BLUE 80 HOSPITAL

K970886 is an FDA 510(k) clearance for HANAULUX BLUE 80 HOSPITAL, manufactured by Heraeus Med GmbH. The device is a Class 2 General & Plastic Surgery device with product code FSS cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K970886 · Heraeus Med GmbH · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1997
Decision
69d
Days
Class 2
Risk

K970886 is an FDA 510(k) clearance for the HANAULUX BLUE 80 HOSPITAL. Classified as Light, Surgical, Floor Standing (product code FSS), Class II - Special Controls.

Submitted by Heraeus Med GmbH (Hanau, DE). The FDA issued a Cleared decision on April 16, 1997 after a review of 69 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4580 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Heraeus Med GmbH devices

FDA 510(k) Submission Details - K970886

510(k) Number K970886 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 1997
Decision Date April 16, 1997
Days to Decision 69 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 115d · This submission: 69d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FSS Device Classification - Class 2, Special Controls

Product Code FSS Light, Surgical, Floor Standing
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4580
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - FSS Light, Surgical, Floor Standing

All 9
Devices cleared under the same product code (FSS) and FDA review panel - the closest regulatory comparables to K970886.
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K961074 · Cuda Products Co. · Apr 1996
LIGHT, SURGICAL, FLOOR STANDING
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