Cleared Traditional

K181286 - Ambu aScope RLS Slim

K181286 is the FDA 510(k) clearance for Ambu aScope RLS Slim 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 198-day FDA review.

K181286 · Ambu A/S · Ear, Nose, Throat device
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Nov 2018
Decision
198d
Days
Class 2
Risk

K181286 is an FDA 510(k) clearance for the Ambu aScope RLS 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 November 30, 2018 after a review of 198 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 Ambu A/S devices

Submission Details

510(k) Number K181286 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 2018
Decision Date November 30, 2018
Days to Decision 198 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
109d slower than avg
Panel avg: 89d · This submission: 198d
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 K181286.
CMOS Video-Rhino-Laryngoscope System
K182186 · KARL STORZ Endoscopy-America, Inc. · Mar 2019
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K182102 · Olympus Medical Systems Corp. · Feb 2019
PENTAX Medical EPK-3000 Video Imaging System
K182846 · Pentax of America, Inc. · Jan 2019
Rhino-Laryngo Fiberscope Olympus ENF-GP2
K181240 · Olympus Medical Systems Corp. · Oct 2018
PENTAX Medical VIVIDEO ENT Videoscope Solution
K171011 · Pentax Medical · Jul 2018
Sharpsite AC Rigid Endsocope
K173855 · Medtronic Xomed, Inc. · Apr 2018