Cleared Traditional

TK Insulin Syringe with/without Saftey Retractable Device (K191639) - FDA 510(k) Clearance

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

K191639 · Anhui Tiankang Medical Technology Co., Ltd. · General Hospital
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Sep 2020
Decision
450d
Days
Class 2
Risk

K191639 is an FDA 510(k) clearance for the TK Insulin Syringe with/without Saftey Retractable Device. Classified as Syringe, Antistick (product code MEG), Class II - Special Controls.

Submitted by Anhui Tiankang Medical Technology Co., Ltd. (Tianchang, CN). The FDA issued a Cleared decision on September 11, 2020 after a review of 450 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Anhui Tiankang Medical Technology Co., Ltd. devices

Submission Details

510(k) Number K191639 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 2019
Decision Date September 11, 2020
Days to Decision 450 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
321d slower than avg
Panel avg: 129d · This submission: 450d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MEG Syringe, Antistick
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 - MEG Syringe, Antistick

All 38
Devices cleared under the same product code (MEG) and FDA review panel - the closest regulatory comparables to K191639.
Sterile Syringe With Safety Needle
K211753 · Jiangxi Hongda Medical Equipment Group , Ltd. · Oct 2021
DR Safety Syringe, Sterile Hypodermic needle for Single use
K212226 · Zhuhai DR Medical Instruments Co., Ltd. · Sep 2021
Insulin Syringe, Insulin Syringe with Safety Retractable
K202570 · Jiangsu Micsafe Medical Technology Co., Ltd. · Jul 2021
1ml Luer Slip or Luer Lock Syringe, Syringe with permanently attached needle, Safety Syringe with permanently attached needle
K192551 · Jiangsu Caina Medical Co.,Ltd · Aug 2020
Retractable Safety Insulin Syringe
K193022 · Jiangsu Caina Medical Co.,Ltd · Jul 2020
Sterile Syringe with Safety needle for Single Use, Sterile Syringe for Single Use, Sterile Safety Needle for Single Use
K192679 · Gemtier Medical (Shanghai), Inc. · Apr 2020