Cleared Traditional

K161255 - meso-relle (AAL34, AAL36, AM30G)

K161255 is an FDA 510(k) clearance for meso-relle (AAL34, manufactured by Biotekne Srl. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 261-day FDA review.

K161255 · Biotekne Srl · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2017
Decision
261d
Days
Class 2
Risk

K161255 is an FDA 510(k) clearance for the meso-relle (AAL34, AAL36, AM30G). Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Biotekne Srl (Casalecchio Di Reno, IT). The FDA issued a Cleared decision on January 19, 2017 after a review of 261 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.

FDA 510(k) Submission Details - K161255

510(k) Number K161255 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 2016
Decision Date January 19, 2017
Days to Decision 261 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
132d slower than avg
Panel avg: 129d · This submission: 261d
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

Studio DI Ingegneria Enrico Bisson
Enrico Bisson

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 581
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K161255.
Mini Needle
K170768 · Ocuject, LLC · Jul 2017
Common Type Insulin Pen Needle, Safety Type Insulin Pen Needle
K161950 · Promisemed Hangzhou Meditech Co., Ltd. · May 2017
Safety Blood Collection Set
K163093 · Jiangsu Shenli Medical Production Co., Ltd. · Mar 2017
BD Pen Needle
K162516 · Becton, Dickinson and Company · Dec 2016
Greiner Holdex
K160532 · Greiner Bio-One Na, Inc. · Nov 2016
Advocate Insulin Pen Needles
K160199 · Diabetic Supply of Suncoast, Inc. · Oct 2016