Cleared Traditional

K190972 - Ambu aScope 4 RhinoLaryngo Intervention

K190972 is the FDA 510(k) clearance for Ambu aScope 4 RhinoLaryngo Intervention by Ambu A/S. It is a Class 2 Ear, Nose, Throat device (product code EOB) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K190972 · Ambu A/S · Ear, Nose, Throat device
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Jul 2019
Decision
88d
Days
Class 2
Risk

K190972 is an FDA 510(k) clearance for the Ambu aScope 4 RhinoLaryngo Intervention. Classified as Nasopharyngoscope (flexible Or Rigid) (product code EOB), Class II - Special Controls.

Submitted by Ambu A/S (Ballerup, DK). The FDA issued a Cleared decision on July 12, 2019 after a review of 88 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 Ambu A/S devices

Submission Details

510(k) Number K190972 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 2019
Decision Date July 12, 2019
Days to Decision 88 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
1d faster than avg
Panel avg: 89d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EOB Nasopharyngoscope (flexible Or Rigid)
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 Consultant

Ambu, Inc.
Sanjay Parikh

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - EOB Nasopharyngoscope (flexible Or Rigid)

All 86
Devices cleared under the same product code (EOB) and FDA review panel - the closest regulatory comparables to K190972.
CMOS Video Rhino-Laryngoscope SSU
K192090 · Karl Storz SE & CO. KG · Jan 2020
Rhino-Laryngo Videoscope Olympus ENF-VT3
K183416 · Olympus Medical Systems Corp. · Sep 2019
Precision S 4K Sinuscope
K191102 · Stryker · Sep 2019
PENTAX Medical ENT Video Imaging System
K183691 · Pentax of America, Inc. · Jun 2019
Ambu aScope 4 RhinoLaryngo Slim
K191080 · Ambu A/S · May 2019
CMOS Video-Rhino-Laryngoscope System
K182186 · KARL STORZ Endoscopy-America, Inc. · Mar 2019