Cleared Traditional

K131850 - TENSYN BAND

K131850 is an FDA 510(k) clearance for TENSYN BAND, manufactured by Dallen Medical, Inc.. The device is a Class 2 Orthopedic device with product code HTN cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K131850 · Dallen Medical, Inc. · Orthopedic device
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Nov 2013
Decision
147d
Days
Class 2
Risk

K131850 is an FDA 510(k) clearance for the TENSYN BAND. Classified as Washer, Bolt Nut (product code HTN), Class II - Special Controls.

Submitted by Dallen Medical, Inc. (San Clemente, US). The FDA issued a Cleared decision on November 15, 2013 after a review of 147 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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. Standard predicate reliance. 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, Inc. devices

FDA 510(k) Submission Details - K131850

510(k) Number K131850 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 2013
Decision Date November 15, 2013
Days to Decision 147 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
25d slower than avg
Panel avg: 122d · This submission: 147d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HTN Device Classification - Class 2, Special Controls

Product Code HTN Washer, Bolt Nut
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - HTN Washer, Bolt Nut

All 70
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