Cleared Traditional

K151090 - CPL Insulin Pen Needle

K151090 is an FDA 510(k) clearance for CPL Insulin Pen Needle, manufactured by Cpl Co., Ltd.. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 517-day FDA review.

K151090 · Cpl Co., Ltd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2016
Decision
517d
Days
Class 2
Risk

K151090 is an FDA 510(k) clearance for the CPL Insulin Pen Needle. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Cpl Co., Ltd. (Ansan, KR). The FDA issued a Cleared decision on September 21, 2016 after a review of 517 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5570 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

FDA 510(k) Submission Details - K151090

510(k) Number K151090 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 2015
Decision Date September 21, 2016
Days to Decision 517 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
388d slower than avg
Panel avg: 129d · This submission: 517d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMI Device Classification - Class 2, Special Controls

Product Code FMI Needle, Hypodermic, Single Lumen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5570
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

Plusglobal
PETER CHUNG

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 - FMI Needle, Hypodermic, Single Lumen

All 581
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K151090.
BD Pen Needle
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