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 Shiley, Inc., KARL STORZ Endoscopy-America, Inc. and Edward Weck, Inc..
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
Cleared
May 15, 2026
KARL STORZ Laryngoscopes and Accessories
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat
270d
Cleared
Dec 18, 1979
SHILEY LOW PRESSURE THIN-CUFFED TRACH.
Shiley, Inc.
Ear, Nose, Throat
43d
Cleared
Oct 24, 1978
SHILEY CRICOTHYROTOMY TUBE
Shiley, Inc.
Ear, Nose, Throat
33d
Cleared
Jan 21, 1977
ROBBETT MICROSURGICAL LARYNGOSCOPE
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 →