Cleared Traditional

DROPLET PEN NEEDLE (K171982) - FDA 510(k) Clearance

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

K171982 · Htl-Strefa S.A · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2018
Decision
264d
Days
Class 2
Risk

K171982 is an FDA 510(k) clearance for the DROPLET 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 March 21, 2018 after a review of 264 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

Submission Details

510(k) Number K171982 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 2017
Decision Date March 21, 2018
Days to Decision 264 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
135d slower than avg
Panel avg: 129d · This submission: 264d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 198
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K171982.
RELI Safety Blood Collection Tube Holder, RELI Blood Collection Tube Holder
K173279 · Myco Medical Supplies, Inc. · May 2018
VACUETTE EVOPROTECT Safety Blood Collection / Infusion Set
K173757 · Greiner Bio-One Na, Inc. · Apr 2018
FAST1™ Intraosseous Infusion System
K180588 · Teleflex Medical · Apr 2018
NovoFine 32G Tip (0.23/0.25) x 6 mm ETW (extra thin wall)
K173479 · Novo Nordisk, Inc. · Jan 2018
BD Pen Needle
K162516 · Becton, Dickinson and Company · Dec 2016
Cook Intraosseous Infusion Needles
K160887 · Cook Incorporated · Jul 2016