Cleared Traditional

K191659 - Instylla Delivery Kit

K191659 is an FDA 510(k) clearance for Instylla Delivery Kit, manufactured by Instylla, Inc.. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K191659 · Instylla, Inc. · General Hospital
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Oct 2019
Decision
111d
Days
Class 2
Risk

K191659 is an FDA 510(k) clearance for the Instylla Delivery Kit. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Instylla, Inc. (Waltham, US). The FDA issued a Cleared decision on October 10, 2019 after a review of 111 days - within the typical 510(k) review window.

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 Instylla, Inc. devices

FDA 510(k) Submission Details - K191659

510(k) Number K191659 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 2019
Decision Date October 10, 2019
Days to Decision 111 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
18d faster than avg
Panel avg: 129d · This submission: 111d
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 Peers - FMF Syringe, Piston

All 329
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K191659.
Tamper Evident Cap
K193192 · International Medical Industries, Inc. · Jan 2020
TK Sterile Piston Syringe without Needle
K191642 · Anhui Tiankang Medical Technology Co., Ltd. · Jan 2020
BD Insulin Syringe
K190054 · Becton, Dickinson and Company · Oct 2019
Nipro Syringe
K191359 · Nipro Medical Corporation · Oct 2019
EpiFaith Syringe
K192421 · Flat Medical Co., Ltd. · Sep 2019
Sterile Hypodermic Syringe for Single use, with/without needle, Sterile Insulin Syringe for Single use, with needle, Sterile Hypodermic needle for Single use
K190002 · Shanghai Kohope Medical Devices Co., Ltd. · Sep 2019