Cleared Traditional

K150248 - ORL Video NasoPharyngo-Larngoscope

K150248 is an FDA 510(k) clearance for ORL Video NasoPharyngo-Larngoscope, manufactured by Jedmed Instrument Company. The device is a Class 2 Ear, Nose, Throat device with product code EQN cleared through the Traditional 510(k) pathway after a 170-day FDA review.

K150248 · Jedmed Instrument Company · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2015
Decision
170d
Days
Class 2
Risk

K150248 is an FDA 510(k) clearance for the ORL Video NasoPharyngo-Larngoscope. Classified as Laryngoscope, Nasopharyngoscope (product code EQN), Class II - Special Controls.

Submitted by Jedmed Instrument Company (Saint Louis, US). The FDA issued a Cleared decision on July 23, 2015 after a review of 170 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Jedmed Instrument Company devices

FDA 510(k) Submission Details - K150248

510(k) Number K150248 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 2015
Decision Date July 23, 2015
Days to Decision 170 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
81d slower than avg
Panel avg: 89d · This submission: 170d
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 K150248.
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