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
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 130d · 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 302
Devices cleared under the same product code (KNT) and FDA review panel - the closest regulatory comparables to K070449.
ENTERAL ONLY EXTENSION SET
K082654 · Respironics, Inc. · Nov 2008
BARD DIGNICARE STOOL MANAGEMENT SYSTEM
K073598 · C.R. Bard, Inc. · Jun 2008
THROUGH-THE-PEG (TTP) JEJUNOSTOMY TUBE KIT
K072476 · Boston Scientific Corporation · Dec 2007
BARD BALLOON DILATION KIT WITH TRIFUNNEL GASTROSTOMY TUBE
K063118 · C.R. Bard, Inc. · Feb 2007
HOSPIRA ENTERAL FEEDING SET, MODEL 20640
K061432 · Hospira, Inc. · Sep 2006
ENTAKE STANDARD AND SAFETY PEG SYSTEM
K061021 · Conmedcorp · Apr 2006