Cleared Traditional

K760877 - MONOJECT LARYNGOTRACHEAL ANESTHESIA KIT (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K760877 · Sherwood Medical Industries · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1976
Decision
66d
Days
Class 2
Risk

K760877 is an FDA 510(k) clearance for the MONOJECT LARYNGOTRACHEAL ANESTHESIA KIT. Classified as Applicator (laryngo-tracheal), Topical Anesthesia (product code CCT), Class II - Special Controls.

Submitted by Sherwood Medical Industries (Mchenry, US). The FDA issued a Cleared decision on December 9, 1976 after a review of 66 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5170 - 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.

View all Sherwood Medical Industries devices

Submission Details

510(k) Number K760877 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 1976
Decision Date December 09, 1976
Days to Decision 66 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 139d · This submission: 66d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CCT Applicator (laryngo-tracheal), Topical Anesthesia
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5170
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 Anesthesiology devices follow this clearance model.