510(k) Report

FDA applicant

Seventh Sense Biosystems, Inc.

Medford, MA2 decisions2017–20190 recalls

FDA records 2 decisions for Seventh Sense Biosystems, Inc. (Medford, MA) from 2017 to 2019: 2 510(k) clearances. All are in product code PRJ (Capillary Blood Collection Device For…). Its devices cite 2 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, clinical chemistry panel, where it files most

How often FDA has decided Seventh Sense Biosystems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2019

2017: 12019: 1
2017high 1 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Seventh Sense Biosystems, Inc. by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • PRJCapillary Blood Collection Device For Alternative Site Collection2decisions

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K161521TAP Blood Collection DeviceSeventh Sense Biosystems, Inc. · 20171cites it

What has FDA decided for it lately?

  • K190225TAP Blood Collection DeviceSeventh Sense Biosystems, Inc. · 2019
  • K161521TAP Blood Collection DeviceSeventh Sense Biosystems, Inc. · 2017

All 2 as Seventh Sense Biosystems, Inc. →