Cleared Traditional

PreferX Delivery System (K210997) - FDA 510(k) Clearance

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

K210997 · Md3, LLC · General & Plastic Surgery device
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Sep 2021
Decision
158d
Days
Class 2
Risk

K210997 is an FDA 510(k) clearance for the PreferX Delivery System. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Md3, LLC (Coral Springs, US). The FDA issued a Cleared decision on September 7, 2021 after a review of 158 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Md3, LLC devices

Submission Details

510(k) Number K210997 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 2021
Decision Date September 07, 2021
Days to Decision 158 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
43d slower than avg
Panel avg: 115d · This submission: 158d
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 K210997.
Sterile syringe for single use with/without needle
K210227 · Zhejiang Kangkang Medical-Devices Co., Ltd. · Sep 2021
Promisemed Sterile Hypodermic Syringes, Verifine Sterile Hypodermic Syringes
K211242 · Promisemed Hangzhou Meditech Co., Ltd. · Sep 2021
Verifine Mechanical Safety Insulin Syringe
K210712 · Promisemed Hangzhou Meditech Co., Ltd. · Sep 2021
Disposable Sterile Syringe, Disposable Sterile Syringe with Needle
K210991 · Guangdong Antmed Co., Ltd. · Aug 2021
Auto Disable Syringe
K210464 · Anhui Tiankang Medical Technology Co., Ltd. · Aug 2021
BD Flu+ Syringe
K203359 · Becton, Dickinson and Company · Jul 2021