Cleared Traditional

K020921 - NO-POKES NEEDLE SAFETY DEVICE

K020921 is an FDA 510(k) clearance for NO-POKES NEEDLE SAFETY DEVICE, manufactured by Bemis Mfg. Co.. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K020921 · Bemis Mfg. Co. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2002
Decision
112d
Days
Class 2
Risk

K020921 is an FDA 510(k) clearance for the NO-POKES NEEDLE SAFETY DEVICE. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Bemis Mfg. Co. (Sheboygan Falls, US). The FDA issued a Cleared decision on July 11, 2002 after a review of 112 days - within the typical 510(k) review window.

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 Bemis Mfg. Co. devices

FDA 510(k) Submission Details - K020921

510(k) Number K020921 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 2002
Decision Date July 11, 2002
Days to Decision 112 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 129d · This submission: 112d
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 342
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K020921.
MODIFICATION TO BD ULTRA-FINE III PEN NEEDLE
K031200 · Becton, Dickinson & CO · Jun 2003
BD ULTRA-FINE III PEN NEEDLE
K024109 · Becton, Dickinson & CO · Dec 2002
SURE-LOK
K021315 · Vital Signs, Inc. · Aug 2002
NIPRO HYPODERMIC NEEDLE
K013293 · Nipro Medical Corp. · Dec 2001
DISETRONIC PENFINE INSULIN INJECTION PEN NEEDLE
K013782 · Disetronic Medical Systems · Nov 2001
JMS APHERESIS NEEDLE SET ACCORDION TYPE
K002394 · Jms Co., Ltd. · Sep 2001