Cleared Traditional

K921263 - SUNLITE LARYNGOSCOPE

K921263 is an FDA 510(k) clearance for SUNLITE LARYNGOSCOPE, manufactured by Sunmed, Inc.. The device is a Class 1 Anesthesiology device with product code CCW cleared through the Traditional 510(k) pathway after a 442-day FDA review.

K921263 · Sunmed, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1993
Decision
442d
Days
Class 1
Risk

K921263 is an FDA 510(k) clearance for the SUNLITE LARYNGOSCOPE. Classified as Laryngoscope, Rigid (product code CCW), Class I - General Controls.

Submitted by Sunmed, Inc. (Clearwater, US). The FDA issued a Cleared decision on June 1, 1993 after a review of 442 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all Sunmed, Inc. devices

FDA 510(k) Submission Details - K921263

510(k) Number K921263 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 1992
Decision Date June 01, 1993
Days to Decision 442 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
302d slower than avg
Panel avg: 140d · This submission: 442d
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 21
Devices cleared under the same product code (CCW) and FDA review panel - the closest regulatory comparables to K921263.
AUGUSTINE INTUBATION GUIDE
K954446 · Augustine Medical, Inc. · Dec 1995
KARL STORZ SUBGLOTTISCOPE, NEONATE AND INFANT, FIBER OPTIC LIGHT CARRIER, SUCTION TUBE
K951804 · KARL STORZ Endoscopy-America, Inc. · Jun 1995
MCINTOSH, MILLER, FOREGGER BABY
K945425 · Rudolf Riester GmbH & Co. KG · Mar 1995
AUGUSTINE FIBEROPTIC LARYNGOSCOPE
K915161 · Augustine Medical, Inc. · May 1992
AUGUSTINE GUIDE KIT
K921166 · Augustine Medical, Inc. · Apr 1992
BAUMAN DISPOSABLE LARYNGOSCOPE BLADES
K905273 · Vital Signs, Inc. · Mar 1992