Cleared Traditional

K182765 - 5cc Neuraxial Slip Tip Glass Syringe

K182765 is the FDA 510(k) clearance for 5cc Neuraxial Slip Tip Glass Syringe by Top Corporation. It is a Class 2 General Hospital device (product code FMF) cleared through the Traditional 510(k) pathway after a 340-day FDA review.

K182765 · Top Corporation · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2019
Decision
340d
Days
Class 2
Risk

K182765 is an FDA 510(k) clearance for the 5cc Neuraxial Slip Tip Glass Syringe,5cc Neuraxial Lock Tip Glass Syringe,5cc.... Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Top Corporation (Adachi-Ku, JP). The FDA issued a Cleared decision on September 3, 2019 after a review of 340 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Top Corporation devices

Submission Details

510(k) Number K182765 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2018
Decision Date September 03, 2019
Days to Decision 340 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
211d slower than avg
Panel avg: 129d · This submission: 340d
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

Jon Gilbert
Jonathan 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 285
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K182765.
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
Sure-Fine Insulin Syringes
K191531 · Shina Med Corporation · Sep 2019
Bonus Therapeutics Mixing and Delivery System
K190996 · Bonus Therapeutics , Ltd. · Jul 2019
Immucise
K190427 · Terumo Corporation · Jul 2019
EpiFaith Syringe (Luer Slip) , EpiFaith Syringe (NRFit)
K182268 · Flat Medical Co., Ltd. · Apr 2019