Cleared Traditional

K100551 - ORLOCATE SYSTEM MODEL ORL 100

K100551 is an FDA 510(k) clearance for ORLOCATE SYSTEM MODEL ORL 100, manufactured by Haldor Advanced Technologies, Ltd.. The device is a Class 1 General & Plastic Surgery device with product code LWH cleared through the Traditional 510(k) pathway after a 167-day FDA review.

K100551 · Haldor Advanced Technologies, Ltd. · General & Plastic Surgery device
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Aug 2010
Decision
167d
Days
Class 1
Risk

K100551 is an FDA 510(k) clearance for the ORLOCATE SYSTEM MODEL ORL 100. Classified as Counter, Sponge, Surgical (product code LWH), Class I - General Controls.

Submitted by Haldor Advanced Technologies, Ltd. (Pardes Hanna, IL). The FDA issued a Cleared decision on August 12, 2010 after a review of 167 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 880.2740 - the FDA general and plastic surgery 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 & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Haldor Advanced Technologies, Ltd. devices

FDA 510(k) Submission Details - K100551

510(k) Number K100551 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 2010
Decision Date August 12, 2010
Days to Decision 167 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
52d slower than avg
Panel avg: 115d · This submission: 167d
Pathway characteristics
Predicate-based equivalence.

LWH Device Classification - Class 1, General Controls

Product Code LWH Counter, Sponge, Surgical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.2740
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.