Cleared Traditional

Instylla Delivery Kit (K191659) - FDA 510(k) Clearance

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

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

Submission Details

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.

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 Hospital devices follow this clearance model.

Regulatory Peers - FMF Syringe, Piston

All 239
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