510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K103340Substantially Equivalent

Smartprep2 Bmac System, Smartprep Platelet Concentration System

Terumo BCT, Ltd, Plymouth MA / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K103340 is the FDA 510(k) clearance record for SMARTPREP2 BMAC SYSTEM, SMARTPREP PLATELET CONCENTRATION SYSTEM, a class I device, cleared for Harvest Technologies, Corp. on under FDA product code JQC (Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use). FDA records list 13 510(k) clearances for TERUMO BCT, LTD, from to . As of , FDA records show 2 recalls naming K103340.

Clearance record

Decision date
Received
(21 days to decision)
Product code
JQC Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
Regulation
21 CFR 862.2050
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Harvest Technologies, Corp. 40 Grissom Rd., Suite 100, Plymouth MA
510(k) summary
Statement
Third party review
No

Clearances, product code JQC

Trailing 12 months

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

FDA records show no clearances under product code JQC in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JQC, 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