Cleared Traditional

K213158 - Syringe with permanently attached needle

K213158 is an FDA 510(k) clearance for Syringe with permanently attached 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 296-day FDA review.

K213158 · Berpu Medical Technology Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
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Jul 2022
Decision
296d
Days
Class 2
Risk

K213158 is an FDA 510(k) clearance for the Syringe with permanently attached 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 July 21, 2022 after a review of 296 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 - K213158

510(k) Number K213158 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2021
Decision Date July 21, 2022
Days to Decision 296 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
167d slower than avg
Panel avg: 129d · This submission: 296d
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 K213158.
Sterile Hypodermic Syringe for Single Use, with/without Needle, Sterile Hypodermic Needle for Single Use
K212846 · Jiangsu Jichun Medical Devices Co., Ltd. · Aug 2022
Disposable Sterile Syringe, with/without needle
K212033 · Shandong Zhushi Pharmaceutical Group Co., Ltd. · Aug 2022
InstaFill Graft Delivery System, SIGNIFY Bioactive
K221737 · Globus Medical, Inc. · Aug 2022
Pump Alignment Syringe
K220184 · Jiangsu Caina Medical Co.,Ltd · Jul 2022
Disposabel Syringe with permanently attached needle, Safety Syringe with permanently attached needle
K220204 · Anhui Tiankang Medical Technology Co., Ltd. · Jul 2022
Sterile Hypodermic Syringes for Single Use
K213811 · Berpu Medical Technology Co., Ltd. · May 2022