Cleared Traditional

K830888 - COOL-LITE FIBERCOPTIC LARYNGEAL EXAM

K830888 is an FDA 510(k) clearance for COOL-LITE FIBERCOPTIC LARYNGEAL EXAM, manufactured by National Medical Technology. The device is a Class 2 Ear, Nose, Throat device with product code EQN cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K830888 · National Medical Technology · Ear, Nose, Throat device
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Apr 1983
Decision
37d
Days
Class 2
Risk

K830888 is an FDA 510(k) clearance for the COOL-LITE FIBERCOPTIC LARYNGEAL EXAM. Classified as Laryngoscope, Nasopharyngoscope (product code EQN), Class II - Special Controls.

Submitted by National Medical Technology (Mchenry, US). The FDA issued a Cleared decision on April 27, 1983 after a review of 37 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4760 - the FDA ear, nose and throat 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 National Medical Technology devices

FDA 510(k) Submission Details - K830888

510(k) Number K830888 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 1983
Decision Date April 27, 1983
Days to Decision 37 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 89d · This submission: 37d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EQN Device Classification - Class 2, Special Controls

Product Code EQN Laryngoscope, Nasopharyngoscope
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.4760
Definition If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
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 Ear, Nose, Throat devices follow this clearance model.

Regulatory Peers - EQN Laryngoscope, Nasopharyngoscope

All 14
Devices cleared under the same product code (EQN) and FDA review panel - the closest regulatory comparables to K830888.
KARL STORZ Laryngoscopes and Accessories
K252624 · KARL STORZ Endoscopy-America, Inc. · May 2026
ERGO-FLEX LARYNGO-NASOPHARYNGOSCOPE EF-N AND EF-N SLIM
K132039 · Jedmed Instrument Co. · Feb 2014
OP-CON SURG. INSTRUMENT #7
K834172 · Imm Enterprises , Ltd. · Mar 1984
LARYNGOSCOPES RIGID
K822525 · Kelleher Corp. · Sep 1982
NAGASHIMA SFT-I LARYNGOSCOPE RIGHT-ANGL
K821706 · Kelleher Corp. · Jun 1982
NAGASHIMA SFT-II LARYNGOSCOPE STRAIGHT
K821707 · Kelleher Corp. · Jun 1982