Cleared Traditional

K070449 - LUMILOC (TM) SAFETY INTRODUCER NEEDLE

K070449 is an FDA 510(k) clearance for LUMILOC (TM) SAFETY INTRODUCER NEEDLE, manufactured by Specialized Health Products International, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KNT cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K070449 · Specialized Health Products International, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2007
Decision
119d
Days
Class 2
Risk

K070449 is an FDA 510(k) clearance for the LUMILOC (TM) SAFETY INTRODUCER NEEDLE. Classified as Tubes, Gastrointestinal (and Accessories) (product code KNT), Class II - Special Controls.

Submitted by Specialized Health Products International, Inc. (Salt Lake, US). The FDA issued a Cleared decision on June 14, 2007 after a review of 119 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5980 - the FDA gastroenterology and urology 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 Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Specialized Health Products International, Inc. devices

FDA 510(k) Submission Details - K070449

510(k) Number K070449 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 2007
Decision Date June 14, 2007
Days to Decision 119 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 131d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KNT Device Classification - Class 2, Special Controls

Product Code KNT Tubes, Gastrointestinal (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5980
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - KNT Tubes, Gastrointestinal (and Accessories)

All 498
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K070449.
PEF TUBE
K071579 · N.M. Beale Co., Inc. · Nov 2007
GABRIEL BLUE TUBE MAGNETICALLY GUIDED ENTERAL FEEDING TUBE, MODEL GFT-111
K072787 · Syncro Medical Innovations, Inc. · Oct 2007
REALIZE GASTRIC CALIBRATION TUBE, MODELS GCT180, GCT360
K071764 · Obtech Medical Sarl · Oct 2007
GASTROSTOMY REPLACEMENT TUBE, MODEL 253
K070124 · Degania Silicone , Ltd. · May 2007
CORTRAK ENTERAL ACCESS DEVICE, MODEL 20-0900
K063061 · Viasys Medsystems · Apr 2007
BARD BALLOON DILATION KIT WITH TRIFUNNEL GASTROSTOMY TUBE
K063118 · C.R. Bard, Inc. · Feb 2007