Cleared Traditional

K153553 - SiO2 Coated syringe 3 ml

K153553 is an FDA 510(k) clearance for SiO2 Coated syringe 3 ml, manufactured by Sio2 Medical Products. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 158-day FDA review.

K153553 · Sio2 Medical Products · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2016
Decision
158d
Days
Class 2
Risk

K153553 is an FDA 510(k) clearance for the SiO2 Coated syringe 3 ml. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Sio2 Medical Products (Auburn, US). The FDA issued a Cleared decision on May 17, 2016 after a review of 158 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - 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.

FDA 510(k) Submission Details - K153553

510(k) Number K153553 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 2015
Decision Date May 17, 2016
Days to Decision 158 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
29d slower than avg
Panel avg: 129d · This submission: 158d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 586
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K153553.
LITe BIO Delivery System
K160978 · Stryker Corporation · Jul 2016
Sol-M Insulin Syringe, Sol-M TB Syringe
K153537 · Sol-Millennium Medical, Inc. · Jun 2016
HumaPen Savvio
K160668 · Eli Lilly and Company, Inc. · Jun 2016
HumanPen Ergo II
K151686 · Eli Lilly and Company, Inc. · Dec 2015
Merit 20 mL Syringe
K152783 · Merit Medical Systems, Inc. · Dec 2015
Disposable Insulin Syringe
K151949 · Jiangyin Caina Technology Co., Ltd. · Oct 2015