Cleared Traditional

K101484 - COMPRESSYN BAND

K101484 is an FDA 510(k) clearance for COMPRESSYN BAND, manufactured by Dallen Medical. The device is a Class 2 Orthopedic device with product code JDQ cleared through the Traditional 510(k) pathway after a 308-day FDA review.

K101484 · Dallen Medical · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2011
Decision
308d
Days
Class 2
Risk

K101484 is an FDA 510(k) clearance for the COMPRESSYN BAND. Classified as Cerclage, Fixation (product code JDQ), Class II - Special Controls.

Submitted by Dallen Medical (San Clemente, US). The FDA issued a Cleared decision on April 1, 2011 after a review of 308 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3010 - the FDA orthopedic device regulatory 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Dallen Medical devices

FDA 510(k) Submission Details - K101484

510(k) Number K101484 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 2010
Decision Date April 01, 2011
Days to Decision 308 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
186d slower than avg
Panel avg: 122d · This submission: 308d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDQ Device Classification - Class 2, Special Controls

Product Code JDQ Cerclage, Fixation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3010
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 Orthopedic devices follow this clearance model.

Regulatory Peers - JDQ Cerclage, Fixation

All 97
Devices cleared under the same product code (JDQ) and FDA review panel - the closest regulatory comparables to K101484.
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