Cleared Traditional

CCBIO ASCPO Needle (K214004) - FDA 510(k) Clearance

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

K214004 · Cc Biotechnology Corporation · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2022
Decision
357d
Days
Class 2
Risk

K214004 is an FDA 510(k) clearance for the CCBIO ASCPO Needle. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Cc Biotechnology Corporation (Tainan, TW). The FDA issued a Cleared decision on December 13, 2022 after a review of 357 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: 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 Cc Biotechnology Corporation devices

Submission Details

510(k) Number K214004 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 2021
Decision Date December 13, 2022
Days to Decision 357 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
228d slower than avg
Panel avg: 129d · This submission: 357d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Peers - FMI Needle, Hypodermic, Single Lumen

All 196
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K214004.
Insupen Pen needle, Insupen ORIGINAL Pen Needle, Insupen ADVANCED pen needle
K203792 · Pikdare Spa · Jan 2023
BD AutoShield Duo™ Pen Needle
K223286 · Becton, Dickinson and Company · Dec 2022
Sterile Hypodermic Needles for Single Use
K223334 · Zhejiang Kindly Medical Devices Co., Ltd. · Dec 2022
Altaviz Needle Kit
K222681 · Altaviz, LLC · Dec 2022
DropSafeTM SicuraTM
K223353 · Pikdare Spa · Dec 2022
Disposable Insulin Pen Needle
K221178 · Ningbo Medsun Medical Co., Ltd. · Nov 2022