510(k) Report

FDA applicant

Accriva Diagnostics, Inc.

San Diego, CA3 decisions2019–20231 recall

FDA records 3 decisions for Accriva Diagnostics, Inc. (San Diego, CA) from 2019 to 2023: 3 510(k) clearances. Most are in product codes JPA (System, Multipurpose For In Vitro Coagulation…) and FMK (Single Use Only Blood Lancet With An Integral…). Its devices cite 7 predicates, 1 of them its own earlier devices. 1 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, hematology panel, where it files most

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

FDA decisions per year

1in 2023

2019: 12021: 12023: 1
2019high 1 (2019) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

1in 2026

2026 (partial year): 1
2019high 1 (2026) · low 0 (2019)2026

Class I Class II/III not classified

FIG. 1 — Accriva Diagnostics, Inc. by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

See the 510(k) Report

Which product codes does it file in?

  • JPASystem, Multipurpose For In Vitro Coagulation Studies2decisions
  • FMKSingle Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature1decision

Whose devices does it build on?

Its devices cite 7 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.

  • K193041Hemochron Signature EliteAccriva Diagnostics, Inc. · 20191cites it

What has FDA decided for it lately?

  • K223352TenderfootAccriva Diagnostics, Inc. · 2023
  • K202101GEM Hemochron 100 System, GEM Hemochron 100 Activated Clotting Time Plus Test (ACT+), GEM Hemochron 100 Low…Accriva Diagnostics, Inc. · 20211 recall
  • K193041Hemochron Signature EliteAccriva Diagnostics, Inc. · 2019

All 3 as Accriva Diagnostics, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K202101directCHECK ACT-LR whole blood quality control, level 2 Model/Catalog Number: DCGLR-2Apr 30, 2026Class II