Cleared Traditional

K211169 - Bronchoscope System

K211169 is the FDA 510(k) clearance for Bronchoscope System by Shanghai AnQing Medical Instrument Co., Ltd.. It is a Class 2 Ear, Nose, Throat device (product code EOQ) cleared through the Traditional 510(k) pathway after a 219-day FDA review.

K211169 · Shanghai AnQing Medical Instrument Co., Ltd. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2021
Decision
219d
Days
Class 2
Risk

K211169 is an FDA 510(k) clearance for the Bronchoscope System. Classified as Bronchoscope (flexible Or Rigid) (product code EOQ), Class II - Special Controls.

Submitted by Shanghai AnQing Medical Instrument Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on November 24, 2021 after a review of 219 days - an extended review 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. 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 Shanghai AnQing Medical Instrument Co., Ltd. devices

Submission Details

510(k) Number K211169 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 2021
Decision Date November 24, 2021
Days to Decision 219 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
130d slower than avg
Panel avg: 89d · This submission: 219d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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

Guangzhou Osmunda Medical Device Technical Service Co., Ltd.
Shuwen Fan

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 180
Devices cleared under the same product code (EOQ) and FDA review panel - the closest regulatory comparables to K211169.
Vathin Video Bronchoscope System
K213635 · Hunan Vathin Medical Instrument Co., Ltd. · Feb 2022
Broncoflex Agile, Broncoflex Vortex, Screeni
K212886 · Axess Vision Technology · Feb 2022
Flexible Intubation Video Endoscope – Sterile (FIVE-S)
K212656 · Karl Storz Endoscopy America · Dec 2021
GlideScope BFlex 2.8 Single-Use Bronchoscope
K211947 · Verathon Medical (Canada) Ulc · Nov 2021
PENTAX Medical Video Bronchoscope EB11-J10
K210928 · Pentax of America, Inc. · Oct 2021
Single Use Guide Sheath Kit-401, K-402
K212667 · Olympus Medical Systems Corp. · Sep 2021