Cleared Traditional

K252624 - KARL STORZ Laryngoscopes and Accessories

K252624 is the FDA 510(k) clearance for KARL STORZ Laryngoscopes and Accessories by KARL STORZ Endoscopy-America, Inc.. It is a Class 2 Ear, Nose, Throat device (product code EQN) cleared through the Traditional 510(k) pathway after a 270-day FDA review.

K252624 · KARL STORZ Endoscopy-America, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2026
Decision
270d
Days
Class 2
Risk

K252624 is an FDA 510(k) clearance for the KARL STORZ Laryngoscopes and Accessories. Classified as Laryngoscope, Nasopharyngoscope (product code EQN), Class II - Special Controls.

Submitted by KARL STORZ Endoscopy-America, Inc. (El Segundo, US). The FDA issued a Cleared decision on May 15, 2026 after a review of 270 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 KARL STORZ Endoscopy-America, Inc. devices

Submission Details

510(k) Number K252624 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 2025
Decision Date May 15, 2026
Days to Decision 270 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
181d slower than avg
Panel avg: 89d · This submission: 270d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 13
Devices cleared under the same product code (EQN) and FDA review panel - the closest regulatory comparables to K252624.
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
NAGASHIMA LIGHT SOURCE UNIT SL-4
K821708 · Kelleher Corp. · Jun 1982