Cleared Special

K191080 - Ambu aScope 4 RhinoLaryngo Slim

K191080 is the FDA 510(k) clearance for Ambu aScope 4 RhinoLaryngo Slim by Ambu A/S. It is a Class 2 Ear, Nose, Throat device (product code EOB) cleared through the Special 510(k) pathway after a 28-day FDA review.

K191080 · Ambu A/S · Ear, Nose, Throat device
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May 2019
Decision
28d
Days
Class 2
Risk

K191080 is an FDA 510(k) clearance for the Ambu aScope 4 RhinoLaryngo Slim. 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 May 22, 2019 after a review of 28 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Ambu A/S devices

Submission Details

510(k) Number K191080 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 2019
Decision Date May 22, 2019
Days to Decision 28 days
Submission Type Special
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
61d faster than avg
Panel avg: 89d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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 K191080.
Precision S 4K Sinuscope
K191102 · Stryker · Sep 2019
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K190972 · Ambu A/S · Jul 2019
PENTAX Medical ENT Video Imaging System
K183691 · Pentax of America, Inc. · Jun 2019
CMOS Video-Rhino-Laryngoscope System
K182186 · KARL STORZ Endoscopy-America, Inc. · Mar 2019
RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-VH2, RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-V4
K182102 · Olympus Medical Systems Corp. · Feb 2019
PENTAX Medical EPK-3000 Video Imaging System
K182846 · Pentax of America, Inc. · Jan 2019