Cleared Traditional

Droplet Pen Needle 30G & 33G (K202340) - FDA 510(k) Clearance

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

K202340 · Htl-Strefa S.A · General Hospital
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Oct 2020
Decision
59d
Days
Class 2
Risk

K202340 is an FDA 510(k) clearance for the Droplet Pen Needle 30G & 33G. 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 October 15, 2020 after a review of 59 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Htl-Strefa S.A devices

Submission Details

510(k) Number K202340 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 2020
Decision Date October 15, 2020
Days to Decision 59 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
70d faster than avg
Panel avg: 129d · This submission: 59d
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 K202340.
NovoFine Plus 32G Tip x 4 mm
K202005 · Novo Nordisk, Inc. · Dec 2020
Promisemed Triple Safety Pen Needle
K202682 · Promisemed Hangzhou Meditech Co., Ltd. · Nov 2020
Eclipse DermaFlex Cannula
K200017 · Eclipse Medcorp, LLC · Nov 2020
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