510(k) Report

FDA applicant

Esa Biosciences, Inc.

Chelmsford, MA2 decisions2005–200813 recalls

FDA records 2 decisions for Esa Biosciences, Inc. (Chelmsford, MA) from 2005 to 2008: 2 510(k) clearances. Most are in product codes MRG (System, Test, Vitamin D) and DOF (Lead, Atomic Absorption). Its devices cite 2 predicates, 0 of them its own earlier devices. 13 recalls are linked to its devices, 2 Class I.

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 Esa Biosciences, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2008: 1
2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

3in 2026

2007: 22016: 12017: 1, 1 Class I2018: 22021: 1, 1 Class I2022: 12023: 12024: 12026 (partial year): 3
2007high 3 (2026) · low 0 (2008)2026

Class I Class II/III not classified

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

Planning a device like Esa Biosciences, 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?

  • MRGSystem, Test, Vitamin D1decision
  • DOFLead, Atomic Absorption1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 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.

  • K052549Leadcare II Blood Lead Testing SystemEsa Biosciences, Inc. · 20051cites it

What has FDA decided for it lately?

  • K072536Esa Biosciences Inc. Vitamin D HPLC TestEsa Biosciences, Inc. · 2008
  • K052549Leadcare II Blood Lead Testing SystemEsa Biosciences, Inc. · 20052 Class I recalls

All 2 as Esa Biosciences, Inc. →

What has been recalled?

13 recalls linked to its devices; the latest:

  • K052549LeadCare II Blood Lead Test Kit. Model/Catalog Number: 70-6762.Sep 4, 2026Class III
  • K052549(1)(2) LeadCare II Blood Lead Test Kit, (3)LeadCare II 5X Blood Lead Test Kit…Mar 13, 2026Class II
  • K052549LeadCare Ultra Blood Lead Test Kit; Catalog Number: 70-8098; The LeadCare Ultra kit is…Mar 13, 2026Class II
  • K052549The LeadCare II Blood Lead Test System relies on electrochemistry and a unique Sensor to…Feb 23, 2024Class II
  • K052549LeadCare II Blood Lead Test Kit-For in vitro diagnostic use only. The test kit is for…Sep 19, 2023Class II
  • K052549MAGELLAN DIAGNOSTICS LeadCare II Blood Lead Test Kit Rapid Test Kit LeadCare II General…May 25, 2022Class II