Cleared Special

K091279 - NIPRO DISPOSABLE SYRINGE

K091279 is an FDA 510(k) clearance for NIPRO DISPOSABLE SYRINGE, manufactured by Nipro Medical Corporation. The device is a Class 2 General Hospital device with product code FMF cleared through the Special 510(k) pathway after a 103-day FDA review.

K091279 · Nipro Medical Corporation · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2009
Decision
103d
Days
Class 2
Risk

K091279 is an FDA 510(k) clearance for the NIPRO DISPOSABLE SYRINGE. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Nipro Medical Corporation (Miami, US). The FDA issued a Cleared decision on August 12, 2009 after a review of 103 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K091279

510(k) Number K091279 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 2009
Decision Date August 12, 2009
Days to Decision 103 days
Submission Type Special
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
26d faster than avg
Panel avg: 129d · This submission: 103d
Pathway characteristics
Modification to existing cleared device.

FMF Device Classification - Class 2, Special Controls

Product Code FMF Syringe, Piston
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
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 - FMF Syringe, Piston

All 755
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K091279.
NEOMED STERILE SYRINGE, MODELS SD-S1EO, SD-S3EO, SD-S630, SD-S12EO, SD-S20EO, SD-S35EO, SD-S60EO
K092908 · Neomed, Inc. · Mar 2010
ACACIA PISTON SYRINGE
K092986 · Acacia, Inc. · Oct 2009
XTRACT SYRINGE KEYS
K091200 · Xtract Solutions, LLC · Aug 2009
SHINA INSULIN SYRINGE-INCLUDING ACCU-SURE INSULIN SYRINGES
K091167 · Shina Corp. · Aug 2009
EASY.TOUCH INSULIN SYRINGE
K091474 · Masters Healthcare, LLC · Jul 2009
BAIXIN DISPOSABLE SYRINGE, MULTIPLE SIZES
K083686 · Anhui Kangda Medical Products Co., Ltd. · Jul 2009
K091279 · NIPRO DISPOSABLE SYRINGE
Download PDF FDA Summary Nipro Medical Corpora…