Cleared Traditional

Immucise (K190427) - FDA 510(k) Clearance

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

K190427 · Terumo Corporation · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2019
Decision
146d
Days
Class 2
Risk

K190427 is an FDA 510(k) clearance for the Immucise. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Terumo Corporation (Shibuya-Ku, JP). The FDA issued a Cleared decision on July 18, 2019 after a review of 146 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 Terumo Corporation devices

Submission Details

510(k) Number K190427 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 2019
Decision Date July 18, 2019
Days to Decision 146 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
17d slower than avg
Panel avg: 129d · This submission: 146d
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 Consultant

Terumo Medical Corporation
Rudima L. Jackson

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 239
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K190427.
Sure-Fine Insulin Syringes
K191531 · Shina Med Corporation · Sep 2019
5cc Neuraxial Slip Tip Glass Syringe,5cc Neuraxial Lock Tip Glass Syringe,5cc Neuraxial Additive Slip Tip Glass Syringe,10cc Neuraxial Slip Tip Glass Syringe,10cc Neuraxial Lock Tip Glass Syringe
K182765 · Top Corporation · Sep 2019
Bonus Therapeutics Mixing and Delivery System
K190996 · Bonus Therapeutics , Ltd. · Jul 2019
EpiFaith Syringe (Luer Slip) , EpiFaith Syringe (NRFit)
K182268 · Flat Medical Co., Ltd. · Apr 2019
BD Plastipak Syringe
K182589 · Becton, Dickinson and Company · Mar 2019
NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector)
K182387 · Novo Nordisk, Inc. · Dec 2018