Cleared Traditional

K221045 - Insulin Syringes without needle

K221045 is an FDA 510(k) clearance for Insulin Syringes without needle, manufactured by Berpu Medical Technology Co., Ltd.. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 209-day FDA review.

K221045 · Berpu Medical Technology Co., Ltd. · General Hospital
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Nov 2022
Decision
209d
Days
Class 2
Risk

K221045 is an FDA 510(k) clearance for the Insulin Syringes without needle. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Berpu Medical Technology Co., Ltd. (Wenzhou, CN). The FDA issued a Cleared decision on November 3, 2022 after a review of 209 days - an extended review cycle.

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 Berpu Medical Technology Co., Ltd. devices

FDA 510(k) Submission Details - K221045

510(k) Number K221045 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 2022
Decision Date November 03, 2022
Days to Decision 209 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
80d slower than avg
Panel avg: 129d · This submission: 209d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMF Device Classification - Class 2, Special Controls

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 329
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K221045.
Sterile Syringes for Single Use
K223678 · Shanghai Kindly Enterprise Development Group Co., Ltd. · Feb 2023
Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety Syringe
K213054 · Medline Industries, Inc. · Dec 2022
Medwell Technology Ltd Syringes, various sizes
K212764 · Medwell Technology, Ltd. · Nov 2022
Disposable Syringe with permanently attached needle, Safety Syringe with permanently attached needle
K221308 · Jiangxi Maidikang Medical Devices Co., Ltd. · Oct 2022
Sol-M Luer Lock Syringe
K222744 · Sol-Millennium Medical, Inc. · Oct 2022
Sterile Hypodermic Syringes for Single Use with Needles
K221068 · Sichuan Prius Biotechnology Co., Ltd. · Oct 2022