Cleared Traditional

K852994 - REICHERT FLEXIBLE LARYNGOSCOPE, MODEL LS-11

K852994 is an FDA 510(k) clearance for REICHERT FLEXIBLE LARYNGOSCOPE, manufactured by Reichert-Jung, Inc.. The device is a Class 1 Anesthesiology device with product code CAL cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K852994 · Reichert-Jung, Inc. · Anesthesiology device
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Jul 1985
Decision
14d
Days
Class 1
Risk

K852994 is an FDA 510(k) clearance for the REICHERT FLEXIBLE LARYNGOSCOPE, MODEL LS-11. Classified as Laryngoscope, Non-rigid (product code CAL), Class I - General Controls.

Submitted by Reichert-Jung, Inc. (Southbridge, US). The FDA issued a Cleared decision on July 29, 1985 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5530 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K852994

510(k) Number K852994 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 1985
Decision Date July 29, 1985
Days to Decision 14 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
126d faster than avg
Panel avg: 140d · This submission: 14d
Pathway characteristics
Predicate-based equivalence.

CAL Device Classification - Class 1, General Controls

Product Code CAL Laryngoscope, Non-rigid
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5530
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 - CAL Laryngoscope, Non-rigid

All 7
Devices cleared under the same product code (CAL) and FDA review panel - the closest regulatory comparables to K852994.
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