510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K943966Substantially Equivalent

Vivapore 2

Vivascience, Inc., Acton MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K943966 is the FDA 510(k) clearance record for VIVAPORE 2, a class I device, cleared for Vivascience, Inc. on under FDA product code JJH (Clinical Sample Concentrator). FDA records list 3 510(k) clearances for Vivascience, Inc., from to . As of , FDA records show no recalls naming K943966.

Clearance record

Decision date
Received
(257 days to decision)
Product code
JJH Clinical Sample Concentrator
Regulation
21 CFR 862.2310
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Vivascience, Inc. P.O. Box 2240, Acton MA
510(k) summary
Statement
Third party review
No

Clearances, product code JJH

Trailing 12 months

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

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