Cleared Special

aScope 4 Broncho Regular Sampler Set 5.0/2.2, aScope 4 Broncho Large Sampler Set 5.8/2.8 (K210883) - FDA 510(k) Clearance

Class II Ear, Nose, Throat device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K210883 · Ambu A/S · Ear, Nose, Throat device
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Optimized for regulatory review, auditing and printing
Jun 2021
Decision
84d
Days
Class 2
Risk

K210883 is an FDA 510(k) clearance for the aScope 4 Broncho Regular Sampler Set 5.0/2.2, aScope 4 Broncho Large Sampler .... Classified as Bronchoscope (flexible Or Rigid) (product code EOQ), Class II - Special Controls.

Submitted by Ambu A/S (Ballerup, DK). The FDA issued a Cleared decision on June 17, 2021 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4680 - 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 K210883 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 2021
Decision Date June 17, 2021
Days to Decision 84 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
5d faster than avg
Panel avg: 89d · This submission: 84d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code EOQ Bronchoscope (flexible Or Rigid)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.4680
Definition A Bronchoscope (flexible Or Rigid) And Accessories Is A Tubular Endoscopic Device With Any Of A Group Of Accessory Devices Which Attach To The Bronchoscope And Is Intended To Examine Or Treat The Larynx And Tracheobronchial Tree. If The Device Is Reprocessed, Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission. 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 - EOQ Bronchoscope (flexible Or Rigid)

All 136
Devices cleared under the same product code (EOQ) and FDA review panel - the closest regulatory comparables to K210883.
EXALT Model B Single-Use Bronchoscope (Slim), EXALT Model B Single-Use Bronchoscope (Regular), EXALT Model B Single-Use Bronchoscope (Large), EXALT Monitor
K211030 · Boston Scientific Corporation · Aug 2021
Broncho Videoscope System
K210379 · Scivita Medical Technology Co., Ltd. · Jul 2021
Monarch Platform
K211493 · Auris Health, Inc. · Jul 2021
Rescue Pulmonary Grasping Forceps
K202987 · Anrei Medical (Hangzhou) Co., Ltd. · Apr 2021
SPiN Vision Video Bronchoscope System
K202346 · Veran Medical Technologies, Inc. · Feb 2021
Airway Mobilescope
K201300 · Olympus Medical Systems Corp. · Jan 2021