Cleared Traditional

K213060 - AreusTM Endobronchial Ultrasound Aspira...

K213060 is the FDA 510(k) clearance for AreusTM Endobronchial Ultrasound Aspira... by Micro-Tech (Nanjing) Co., Ltd.. It is a Class 2 Anesthesiology device (product code KTI) cleared through the Traditional 510(k) pathway after a 301-day FDA review.

K213060 · Micro-Tech (Nanjing) Co., Ltd. · Anesthesiology device
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Jul 2022
Decision
301d
Days
Class 2
Risk

K213060 is an FDA 510(k) clearance for the AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial U.... Classified as Bronchoscope Accessory (product code KTI), Class II - Special Controls.

Submitted by Micro-Tech (Nanjing) Co., Ltd. (Nanjing, CN). The FDA issued a Cleared decision on July 20, 2022 after a review of 301 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 874.4680 - the FDA anesthesiology and respiratory 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Micro-Tech (Nanjing) Co., Ltd. devices

Submission Details

510(k) Number K213060 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 2021
Decision Date July 20, 2022
Days to Decision 301 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
161d slower than avg
Panel avg: 140d · This submission: 301d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KTI Bronchoscope Accessory
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.4680
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 Anesthesiology devices follow this clearance model.

Regulatory Peers - KTI Bronchoscope Accessory

All 23
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