Cleared Traditional

K170988 - DropSafe Safety Pen Needle

K170988 is an FDA 510(k) clearance for DropSafe Safety Pen Needle, manufactured by Htl-Strefa S.A. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 253-day FDA review.

K170988 · Htl-Strefa S.A · General Hospital
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Dec 2017
Decision
253d
Days
Class 2
Risk

K170988 is an FDA 510(k) clearance for the DropSafe Safety Pen Needle. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Htl-Strefa S.A (Ozorkow, PL). The FDA issued a Cleared decision on December 12, 2017 after a review of 253 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 S.A devices

FDA 510(k) Submission Details - K170988

510(k) Number K170988 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 2017
Decision Date December 12, 2017
Days to Decision 253 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
124d slower than avg
Panel avg: 129d · This submission: 253d
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 285
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K170988.
FAST1™ Intraosseous Infusion System
K180588 · Teleflex Medical · Apr 2018
DROPLET PEN NEEDLE
K171982 · Htl-Strefa S.A · Mar 2018
NovoFine 32G Tip (0.23/0.25) x 6 mm ETW (extra thin wall)
K173479 · Novo Nordisk, Inc. · Jan 2018
Common Type Insulin Pen Needle, Safety Type Insulin Pen Needle
K161950 · Promisemed Hangzhou Meditech Co., Ltd. · May 2017
BD Pen Needle
K162516 · Becton, Dickinson and Company · Dec 2016
Cook Intraosseous Infusion Needles
K160887 · Cook Incorporated · Jul 2016