Cleared Traditional

K191642 - TK Sterile Piston Syringe without Needle (FDA 510(k) Clearance)

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

K191642 · Anhui Tiankang Medical Technology Co., Ltd. · General Hospital
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Jan 2020
Decision
201d
Days
Class 2
Risk

K191642 is an FDA 510(k) clearance for the TK Sterile Piston Syringe without Needle. 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 January 6, 2020 after a review of 201 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 K191642 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 2019
Decision Date January 06, 2020
Days to Decision 201 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d slower than avg
Panel avg: 128d · This submission: 201d
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 748
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K191642.
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