Cleared Traditional

K143437 - Droplet Pen Needles

K143437 is an FDA 510(k) clearance for Droplet Pen Needles, 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 206-day FDA review.

K143437 · Htl-Strefa S.A · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2015
Decision
206d
Days
Class 2
Risk

K143437 is an FDA 510(k) clearance for the Droplet Pen Needles. 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 June 25, 2015 after a review of 206 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 - K143437

510(k) Number K143437 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 2014
Decision Date June 25, 2015
Days to Decision 206 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
77d slower than avg
Panel avg: 129d · This submission: 206d
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 273
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K143437.
Cook Intraosseous Infusion Needles
K160887 · Cook Incorporated · Jul 2016
BD SafeAssist
K161553 · Becton, Dickinson and Company · Jul 2016
BD Eclipse Hypodermic Needle
K161170 · Becton, Dickinson and Company · May 2016
K-Pack II Needle - 29G x 5/16 Thin Wall
K151398 · Terumo Europe N.V. · Jun 2015
K-Pack II Needle-21G x 2
K150263 · Terumo Europe N.V. · Apr 2015
K-PACK II NEEDLE - 27G X 3/4 THIN WALL
K132233 · Terumo Europe N.V. · Sep 2013