Cleared Traditional

Allograft MIS Delivery System (K201338) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K201338 · Lifenet Health · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Jul 2020
Decision
54d
Days
Class 2
Risk

K201338 is an FDA 510(k) clearance for the Allograft MIS Delivery System. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Lifenet Health (Virginia Beach, US). The FDA issued a Cleared decision on July 13, 2020 after a review of 54 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 880.5860 - the FDA general and plastic surgery 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Lifenet Health devices

Submission Details

510(k) Number K201338 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 2020
Decision Date July 13, 2020
Days to Decision 54 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 115d · This submission: 54d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FMF Syringe, Piston
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
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 & Plastic Surgery devices follow this clearance model.

Regulatory Peers - FMF Syringe, Piston

All 241
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K201338.
Syringe with safety needle, Safety needle
K193526 · Jiangsu Caina Medical Co.,Ltd · Jul 2020
BD SoloShot Mini Syringe/ BD Auto Disable Syringe
K201234 · Becton, Dickinson and Company · Jul 2020
Orbit Subretinal Delivery System
K200325 · Orbit Biomedical · Jul 2020
Aspire Mechanical Aspirator G
K200629 · Control Medical Technology · May 2020
3D GraftRasp System
K200431 · Surgentec · May 2020
O-Genesis Graft Delivery System
K200606 · Orthofix, Inc. · May 2020