510(k) Report

FDA applicant

Lifescience Plus, Inc.

Mystic, CT4 decisions2007–20260 recalls

FDA records 4 decisions for Lifescience Plus, Inc. (Mystic, CT) from 2007 to 2026: 4 510(k) clearances. All are in product code QSY (Hemostatic Wound Dressing Without Thrombin Or…). Its devices cite 5 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

How often FDA has decided Lifescience Plus, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2007: 22016: 12026 (partial year): 1
2007high 2 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Lifescience Plus, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Lifescience Plus, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • QSYHemostatic Wound Dressing Without Thrombin Or Other Biologics4decisions

Whose devices does it build on?

Its devices cite 5 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 8 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K072681Bloodstop Hemostatic Gauze; IX Hemostatic GauzeLifescience Plus, Inc. · 20075cite it
  • K071578Bloodstop and Bloodstop IX Hemostatic Gauze, Models BS-10,BS-11,BS-12,B-13, BS-IX27, BS-IX-14, Bsix-15…Lifescience Plus, Inc. · 20073cite it

What has FDA decided for it lately?

  • K253017BloodSTOP iX Trauma Matrix (TM-iX-20)Lifescience Plus, Inc. · 2026
  • K160130BloodSTOP iX Battle MatrixLifescience Plus, Inc. · 2016
  • K072681Bloodstop Hemostatic Gauze; IX Hemostatic GauzeLifescience Plus, Inc. · 2007
  • K071578Bloodstop and Bloodstop IX Hemostatic Gauze, Models BS-10,BS-11,BS-12,B-13, BS-IX27, BS-IX-14, Bsix-15…Lifescience Plus, Inc. · 2007

All 4 as Lifescience Plus, Inc. →