510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K913306Substantially Equivalent

Bone-Temno/sternum-Temno

Proact, Ltd., State College PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K913306 is the FDA 510(k) clearance record for BONE-TEMNO/STERNUM-TEMNO, a class II device, cleared for Proact, Ltd. on under FDA product code LWE (Bone Marrow Collection/Transfusion Kit). FDA's definition for product code LWE reads: "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...". FDA records list 7 510(k) clearances for Proact, Ltd., from to . As of , FDA records show 5 recalls naming K913306.

Clearance record

Decision date
Received
(99 days to decision)
Product code
LWE Bone Marrow Collection/Transfusion Kit
Device class
Class II
Review panel
Unknown
Applicant
Proact, Ltd. Calder Sq. Box 11029, State College PA
510(k) summary
Statement
Third party review
No

Clearances, product code LWE

Trailing 12 months

FDA records hold no clearances under product code LWE in the trailing twelve months.

FDA records show no clearances under product code LWE in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LWE, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260