Cleared Traditional

K913306 - BONE-TEMNO/STERNUM-TEMNO

K913306 is an FDA 510(k) clearance for BONE-TEMNO/STERNUM-TEMNO, manufactured by Proact, Ltd.. The device is a Class 2 General Hospital device with product code LWE cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K913306 · Proact, Ltd. · General Hospital
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Nov 1991
Decision
99d
Days
Class 2
Risk

K913306 is an FDA 510(k) clearance for the BONE-TEMNO/STERNUM-TEMNO. Classified as Bone Marrow Collection/transfusion Kit (product code LWE), Class II - Special Controls.

Submitted by Proact, Ltd. (State College, US). The FDA issued a Cleared decision on November 1, 1991 after a review of 99 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel. 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 Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Proact, Ltd. devices

FDA 510(k) Submission Details - K913306

510(k) Number K913306 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 1991
Decision Date November 01, 1991
Days to Decision 99 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 129d · This submission: 99d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LWE Device Classification - Class 2, Special Controls

Product Code LWE Bone Marrow Collection/transfusion Kit
Device Class Class 2 - Special Controls
Definition This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html.this Type Of Convenience Kit, As Listed In The Guidance Above, Is Under Enforcement Discretion, And Does Not Require A Premarket Notification (510(k)) To Market If It Meets All Criteria In The Guidance.
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 General Hospital devices follow this clearance model.