Cleared Traditional

K171131 - MHC Standard and NRFit Tip Syringes

K171131 is an FDA 510(k) clearance for MHC Standard and NRFit Tip Syringes, manufactured by Mazza Healthcare, LLC. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 205-day FDA review.

K171131 · Mazza Healthcare, LLC · General Hospital
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Nov 2017
Decision
205d
Days
Class 2
Risk

K171131 is an FDA 510(k) clearance for the MHC Standard and NRFit Tip Syringes. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Mazza Healthcare, LLC (Bannockburn, US). The FDA issued a Cleared decision on November 8, 2017 after a review of 205 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - 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 Mazza Healthcare, LLC devices

FDA 510(k) Submission Details - K171131

510(k) Number K171131 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 2017
Decision Date November 08, 2017
Days to Decision 205 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
76d slower than avg
Panel avg: 129d · This submission: 205d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMF Device Classification - Class 2, Special Controls

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 Hospital devices follow this clearance model.

Regulatory Consultant

Jon Gilbert
Jon Gilbert

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 - FMF Syringe, Piston

All 552
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K171131.
Merit Syringe
K173601 · Merit Medical Systems, Inc. · Jan 2018
Graft Delivery, DePuy Synthes
K173385 · Micromedics, Inc. (D/B/A Nordson Medical) · Nov 2017
DASH 6 NRFit Lock Syringe + Accessories, DASH 6 NRFit Slip Syringe + Accessories, DASH 6 NRFit Plastic LOR Syringe + Accessories
K170900 · Intervene Group, Ltd. · Nov 2017
Luer-Jack Slip 3 ml, Luer-Jack Slip 5 ml, Luer-Jack Slip 20 ml, Luer-Jack Lock 10 ml
K171805 · Conceptomed AS · Sep 2017
Merit Syringe
K171362 · Merit Medical Systems, Inc. · Aug 2017
Graftgun Universal Graft Delivery System
K170675 · SurGenTec, LLC · Jul 2017