Cleared Traditional

K101270 - SWABFLSUH (3ML, 5ML, 10ML) MODEL 10331, 10351, 10311

K101270 is an FDA 510(k) clearance for SWABFLSUH (3ML, manufactured by Excelsior Medical Corp.. The device is a Class 2 General Hospital device with product code NGT cleared through the Traditional 510(k) pathway after a 280-day FDA review.

K101270 · Excelsior Medical Corp. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2011
Decision
280d
Days
Class 2
Risk

K101270 is an FDA 510(k) clearance for the SWABFLSUH (3ML, 5ML, 10ML) MODEL 10331, 10351, 10311. Classified as Saline, Vascular Access Flush (product code NGT), Class II - Special Controls.

Submitted by Excelsior Medical Corp. (Dundas, On, CA). The FDA issued a Cleared decision on February 10, 2011 after a review of 280 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5200 - 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 - K101270

510(k) Number K101270 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 2010
Decision Date February 10, 2011
Days to Decision 280 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
151d slower than avg
Panel avg: 129d · This submission: 280d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NGT Device Classification - Class 2, Special Controls

Product Code NGT Saline, Vascular Access Flush
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5200
Definition Enhance The Performance Of Intravascular Catheters, To Maintain Patency Of The Vascular Catheter When It Is Not In Use.
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 - NGT Saline, Vascular Access Flush

All 40
Devices cleared under the same product code (NGT) and FDA review panel - the closest regulatory comparables to K101270.
AM USA 0.9% SODIUM CHLORIDE FLUSH SYRINGE
K113555 · Am USA · Jan 2012
SODIUM CHLORIDE INJECTION, 0.9%, USP 5 ML, 10 ML AMPULE
K103740 · Spectra Medical Devices, Inc. · Jul 2011
AM USA 0.9% SODIUM CHLORIDE FLUSH SYRINGE
K111034 · Am USA · Jul 2011
FLUSH SYRINGE FILLED WITH 0.9% SODIUM CHLORIDE
K090882 · Hospira, Inc. · Apr 2010
MEDEFIL'S NORMAL SALINE I.V. FLUSH SYRINGE
K091583 · Medefil, Inc. · Jan 2010
STERILE SODIUM CHLORIDE 0.9% FLUSH, 5ML, 10ML, AMPULE
K082689 · Spectra Medical Devices, Inc. · Mar 2009
K101270 · SWABFLSUH (3ML, 5ML, 10ML) MODEL 10331, 10351, 10311
Download PDF FDA Summary Excelsior Medical Cor…