Cleared Traditional

ORLOCATE SYSTEM MODEL ORL 100 (K100551) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

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

Submission Details

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.

Device Classification

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.