Cleared Traditional

Dasky Disposable Sampling Tube (Model name: VSM02) (K211675) - FDA 510(k) Clearance

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K211675 · Ningbo Dasky Life Science Co., Ltd. · Microbiology device
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Aug 2022
Decision
433d
Days
Class 2
Risk

K211675 is an FDA 510(k) clearance for the Dasky Disposable Sampling Tube (Model name: VSM02). Classified as Microbial Nucleic Acid Storage And Stabilization Device (product code QBD), Class II - Special Controls.

Submitted by Ningbo Dasky Life Science Co., Ltd. (Ningbo, CN). The FDA issued a Cleared decision on August 8, 2022 after a review of 433 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2950 - the FDA microbiology 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Microbiology submissions.

View all Ningbo Dasky Life Science Co., Ltd. devices

Submission Details

510(k) Number K211675 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 2021
Decision Date August 08, 2022
Days to Decision 433 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
331d slower than avg
Panel avg: 102d · This submission: 433d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QBD Microbial Nucleic Acid Storage And Stabilization Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.2950
Definition Molecular Transport Media Is A Device Intended For The Stabilization And Transportation Of Nucleic Acids From Unprocessed Human Samples Suspected Of Containing Infectious Material.
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 Microbiology devices follow this clearance model.

Regulatory Peers - QBD Microbial Nucleic Acid Storage And Stabilization Device

All 16
Devices cleared under the same product code (QBD) and FDA review panel - the closest regulatory comparables to K211675.
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