Cleared Traditional

K945425 - MCINTOSH

K945425 is an FDA 510(k) clearance for MCINTOSH, manufactured by Rudolf Riester GmbH & Co. KG. The device is a Class 1 Anesthesiology device with product code CCW cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K945425 · Rudolf Riester GmbH & Co. KG · Anesthesiology device
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Optimized for regulatory review, auditing and printing
Mar 1995
Decision
136d
Days
Class 1
Risk

K945425 is an FDA 510(k) clearance for the MCINTOSH, MILLER, FOREGGER BABY. Classified as Laryngoscope, Rigid (product code CCW), Class I - General Controls.

Submitted by Rudolf Riester GmbH & Co. KG (D-72417 Jungingen, DE). The FDA issued a Cleared decision on March 20, 1995 after a review of 136 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5540 - the FDA anesthesiology and respiratory 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Rudolf Riester GmbH & Co. KG devices

FDA 510(k) Submission Details - K945425

510(k) Number K945425 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 1994
Decision Date March 20, 1995
Days to Decision 136 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 140d · This submission: 136d
Pathway characteristics
Predicate-based equivalence.

CCW Device Classification - Class 1, General Controls

Product Code CCW Laryngoscope, Rigid
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5540
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 - CCW Laryngoscope, Rigid

All 14
Devices cleared under the same product code (CCW) and FDA review panel - the closest regulatory comparables to K945425.
ILLUMINATOR
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