Cleared Traditional

K945507 - H 5100

K945507 is an FDA 510(k) clearance for H 5100, manufactured by Rudolf Riester GmbH & Co. KG. The device is a Class 1 General Hospital device with product code KZF cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K945507 · Rudolf Riester GmbH & Co. KG · General Hospital
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Dec 1994
Decision
30d
Days
Class 1
Risk

K945507 is an FDA 510(k) clearance for the H 5100, H 5200, H 5300. Classified as Device, Medical Examination, Ac Powered (product code KZF), Class I - General Controls.

Submitted by Rudolf Riester GmbH & Co. KG (D-72417 Jungingen, DE). The FDA issued a Cleared decision on December 9, 1994 after a review of 30 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6320 - the FDA general hospital 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 Rudolf Riester GmbH & Co. KG devices

FDA 510(k) Submission Details - K945507

510(k) Number K945507 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 1994
Decision Date December 09, 1994
Days to Decision 30 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 129d · This submission: 30d
Pathway characteristics
Predicate-based equivalence.

KZF Device Classification - Class 1, General Controls

Product Code KZF Device, Medical Examination, Ac Powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6320
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - KZF Device, Medical Examination, Ac Powered

All 11
Devices cleared under the same product code (KZF) and FDA review panel - the closest regulatory comparables to K945507.
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