EQN · Class II · 21 CFR 874.4760

FDA Product Code EQN: Laryngoscope, Nasopharyngoscope

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).

Leading manufacturers include Kelleher Corp., Shiley, Inc. and Jedmed Instrument Co..

22
Total
22
Cleared
60d
Avg days
1977
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Review times increasing: avg 270d recently vs 50d historically

FDA 510(k) Cleared Laryngoscope, Nasopharyngoscope Devices (Product Code EQN)

22 devices
1–22 of 22
Cleared May 15, 2026
KARL STORZ Laryngoscopes and Accessories
K252624
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 270d
Cleared Jul 23, 2015
ORL Video NasoPharyngo-Larngoscope
K150248
Jedmed Instrument Company
Ear, Nose, Throat · 170d
Cleared Feb 21, 2014
ERGO-FLEX LARYNGO-NASOPHARYNGOSCOPE EF-N AND EF-N SLIM
K132039
Jedmed Instrument Co.
Ear, Nose, Throat · 234d
Cleared Mar 06, 1984
OP-CON SURG. INSTRUMENT #7
K834172
Imm Enterprises , Ltd.
Ear, Nose, Throat · 106d
Cleared Sep 09, 1982
LARYNGOSCOPES RIGID
K822525
Kelleher Corp.
Ear, Nose, Throat · 17d
Cleared Jun 25, 1982
NAGASHIMA SFT-I LARYNGOSCOPE RIGHT-ANGL
K821706
Kelleher Corp.
Ear, Nose, Throat · 16d
Cleared Jun 25, 1982
NAGASHIMA SFT-II LARYNGOSCOPE STRAIGHT
K821707
Kelleher Corp.
Ear, Nose, Throat · 16d
Cleared Jun 25, 1982
NAGASHIMA LIGHT SOURCE UNIT SL-4
K821708
Kelleher Corp.
Ear, Nose, Throat · 16d
Cleared Jun 25, 1982
NAGASHIMA LIGHT SOURCE UNIT SL-5
K821709
Kelleher Corp.
Ear, Nose, Throat · 16d
Cleared Jun 25, 1982
NAGASHIMA NX-150F LIGHT SOURCE UNIT
K821710
Kelleher Corp.
Ear, Nose, Throat · 16d
Cleared Jan 22, 1982
CONPHAR LARYNGOSCOPE
K813297
Conphar, Inc.
Ear, Nose, Throat · 60d
Cleared Dec 18, 1979
SHILEY LOW PRESSURE THIN-CUFFED TRACH.
K792222
Shiley, Inc.
Ear, Nose, Throat · 43d
Cleared Dec 15, 1978
TRACH-COLLAR
K782002
Kinetic Concepts, Inc.
Ear, Nose, Throat · 11d
Cleared Oct 24, 1978
SHILEY CRICOTHYROTOMY TUBE
K781639
Shiley, Inc.
Ear, Nose, Throat · 33d
Cleared Jan 21, 1977
ROBBETT MICROSURGICAL LARYNGOSCOPE
K770085
Edward Weck, Inc.
Ear, Nose, Throat · 7d

About Product Code EQN - Regulatory Context

510(k) Submission Activity

22 total 510(k) submissions under product code EQN since 1977, with 22 receiving FDA clearance (average review time: 60 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - EQN Product Code

Recent submissions under EQN have taken an average of 270 days to reach a decision - up from 50 days historically. Manufacturers should account for longer review timelines in current project planning.

EQN devices are reviewed by the Ear, Nose, Throat panel. Browse all Ear, Nose, Throat devices →