510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K161521Substantially Equivalent

TAP Blood Collection Device

Seventh Sense Biosystems, Inc., Medford MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K161521 is the FDA 510(k) clearance record for TAP Blood Collection Device, a class II device, cleared for Seventh Sense Biosystems, Inc. on under FDA product code PRJ (Capillary Blood Collection Device For Alternative Site Collection). FDA's definition for product code PRJ reads: "A capillary blood collection device with or without integrated micro-needles is a blood collection device intended to collect and/or transport capillary whole blood specimens for testing of clinical analytes". FDA records list 2 510(k) clearances for Seventh Sense Biosystems, Inc., from to . As of , FDA records show no recalls naming K161521.

Clearance record

Decision date
Received
(259 days to decision)
Product code
PRJ Capillary Blood Collection Device For Alternative Site Collection
Regulation
21 CFR 862.1675
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Seventh Sense Biosystems, Inc. 200 Boston Ave., Medford MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PRJ

Trailing 12 months

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

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