Cleared Traditional

K191853 - Dual-Safety Pen Needle

K191853 is the FDA 510(k) clearance for Dual-Safety Pen Needle by Promisemed Hangzhou Meditech Co., Ltd.. It is a Class 2 General Hospital device (product code FMI) cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K191853 · Promisemed Hangzhou Meditech Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2019
Decision
57d
Days
Class 2
Risk

K191853 is an FDA 510(k) clearance for the Dual-Safety Pen Needle. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Promisemed Hangzhou Meditech Co., Ltd. (Hangzhou City, CN). The FDA issued a Cleared decision on September 5, 2019 after a review of 57 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 Promisemed Hangzhou Meditech Co., Ltd. devices

Submission Details

510(k) Number K191853 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 2019
Decision Date September 05, 2019
Days to Decision 57 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
72d faster than avg
Panel avg: 129d · This submission: 57d
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 Consultant

Medtech Review, LLC
John Beasley

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FMI Needle, Hypodermic, Single Lumen

All 235
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K191853.
Intraosseous infusion device
K191258 · Einstein Works, LLC · Oct 2019
K-Pack II Needle - 27G x 1/2” Extra Thin Wall, K-Pack II Needle - 27G x 1/2” Ultra Thin Wall, K-Pack II Needle - 30G x 1/2” Extra Thin Wall, K-Pack II Needle - 30G x 1/2” Ultra Thin Wall
K192057 · Terumo Europe N.V. · Oct 2019
NIO-I
K190538 · Waismed, Ltd. · Oct 2019
SteriCap Mini Needle
K183016 · Ocujet, LLC · May 2019
Adult Intraosseous Infusion Device
K182770 · Einstein Works, LLC · Apr 2019
Safety insulin needle for single use
K181447 · Berpu Medical Technology Co., Ltd. · Mar 2019