Cleared Traditional

Droplet Pen Needle 34G (K192082) - FDA 510(k) Clearance

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

K192082 · Htl-Strefa S.A · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2020
Decision
263d
Days
Class 2
Risk

K192082 is an FDA 510(k) clearance for the Droplet Pen Needle 34G. 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 April 21, 2020 after a review of 263 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 K192082 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 2019
Decision Date April 21, 2020
Days to Decision 263 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
134d slower than avg
Panel avg: 129d · This submission: 263d
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 199
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K192082.
Injection Pen Needle
K192464 · Gangan Medical Technology Jiangsu Co., Ltd. · Aug 2020
TK Safety Needle
K191644 · Anhui Tiankang Medical Technology Co., Ltd. · Aug 2020
EZ-Inject Single use Needle
K192222 · Poonglim Pharmatech, Inc. · May 2020
Safety Insulin Pen Needle
K192677 · Jiangsu Caina Medical Co.,Ltd · Feb 2020
Bella-mu
K190962 · U-Needle B.V. · Feb 2020
TK Sterile Hypodermic Needle
K191643 · Anhui Tiankang Medical Technology Co., Ltd. · Dec 2019