Cleared Traditional

K190962 - Bella-mu

K190962 is an FDA 510(k) clearance for Bella-mu, manufactured by U-Needle B.V.. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 297-day FDA review.

K190962 · U-Needle B.V. · General Hospital
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Feb 2020
Decision
297d
Days
Class 2
Risk

K190962 is an FDA 510(k) clearance for the Bella-mu. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by U-Needle B.V. (Enschede, NL). The FDA issued a Cleared decision on February 3, 2020 after a review of 297 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5570 - the FDA general hospital 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all U-Needle B.V. devices

FDA 510(k) Submission Details - K190962

510(k) Number K190962 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 2019
Decision Date February 03, 2020
Days to Decision 297 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
168d slower than avg
Panel avg: 129d · This submission: 297d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMI Device Classification - Class 2, Special Controls

Product Code FMI Needle, Hypodermic, Single Lumen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5570
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 General Hospital devices follow this clearance model.

Regulatory Consultant

Medical Device Academy, Inc.
Robert Packard

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 - FMI Needle, Hypodermic, Single Lumen

All 271
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