Cleared Traditional

Disposabel Syringe with permanently attached needle, Safety Syringe with permanently attached needle (K220204) - FDA 510(k) Clearance

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

K220204 · Anhui Tiankang Medical Technology Co., Ltd. · General Hospital
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Jul 2022
Decision
170d
Days
Class 2
Risk

K220204 is an FDA 510(k) clearance for the Disposabel Syringe with permanently attached needle, Safety Syringe with perm.... Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Anhui Tiankang Medical Technology Co., Ltd. (Tianchang, CN). The FDA issued a Cleared decision on July 14, 2022 after a review of 170 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 Anhui Tiankang Medical Technology Co., Ltd. devices

Submission Details

510(k) Number K220204 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 2022
Decision Date July 14, 2022
Days to Decision 170 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
41d slower than avg
Panel avg: 129d · This submission: 170d
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 Peers - FMF Syringe, Piston

All 239
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K220204.
InstaFill Graft Delivery System, SIGNIFY Bioactive
K221737 · Globus Medical, Inc. · Aug 2022
Syringe with permanently attached needle
K213158 · Berpu Medical Technology Co., Ltd. · Jul 2022
Pump Alignment Syringe
K220184 · Jiangsu Caina Medical Co.,Ltd · Jul 2022
Sterile Hypodermic Syringes for Single Use
K213811 · Berpu Medical Technology Co., Ltd. · May 2022
aboNT SYRINGE
K212677 · Nipro Medical Corporation · Apr 2022
Verifine Safety Syringe with Fixed Needle
K213560 · Promisemed Hangzhou Meditech Co., Ltd. · Apr 2022