Cleared Traditional

K211716 - DropSafe Safety Pen Needles

K211716 is an FDA 510(k) clearance for DropSafe Safety Pen Needles, manufactured by Htl Strefa SA. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 218-day FDA review.

K211716 · Htl Strefa SA · General Hospital
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Jan 2022
Decision
218d
Days
Class 2
Risk

K211716 is an FDA 510(k) clearance for the DropSafe Safety Pen Needles. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Htl Strefa SA (Ozorków, PL). The FDA issued a Cleared decision on January 7, 2022 after a review of 218 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5570 - 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 Htl Strefa SA devices

FDA 510(k) Submission Details - K211716

510(k) Number K211716 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 2021
Decision Date January 07, 2022
Days to Decision 218 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
89d slower than avg
Panel avg: 129d · This submission: 218d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMI Device Classification - Class 2, Special Controls

Product Code FMI Needle, Hypodermic, Single Lumen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5570
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 - FMI Needle, Hypodermic, Single Lumen

All 290
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K211716.
Safety Pen Needle for Single Use, Insulin Pen Needles
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Safety Blood Collection / Infusion Set (with/without needle holder), Blood Collection / Infusion Set (with/without needle holder)
K214075 · Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. · Apr 2022
Safety Pen Needle
K210864 · Sandstone Medical (Suzhou), Inc. · Feb 2022
UltiCare Disposable Pen Needles
K213407 · Ultimed Incorporated · Dec 2021
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BD Nano 2nd Gen Pen Needle
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