510(k) Report

FDA applicant

Sangstat Medical Corp.

Fremont, CA3 decisions1998–19991 recall

FDA records 3 decisions for Sangstat Medical Corp. (Fremont, CA) from 1998 to 1999: 3 510(k) clearances. Most are in product codes DAK (Complement C1q, Antigen, Antiserum, Control) and KYX (Dispenser, Liquid Medication). Its devices cite 3 predicates, 0 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, immunology panel, where it files most

How often FDA has decided Sangstat Medical Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sangstat Medical Corp. since 2007.

Recalls per year

1in 2025

2025: 1
2007high 1 (2025) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Sangstat Medical Corp.’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?

  • DAKComplement C1q, Antigen, Antiserum, Control1decision
  • KYXDispenser, Liquid Medication1decision
  • MSBSystem And Accessories, Isolated Heart, Transport And Preservation1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 times; 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.

  • K991594Celsior Cold Flush, Storage and Transport Solution for HeartsSangstat Medical Corp. · 19995cite it
  • K980109Cyclotech Cyclosporine Oral Solutions DispenserSangstat Medical Corp. · 19981cites it

What has FDA decided for it lately?

  • K991594Celsior Cold Flush, Storage and Transport Solution for HeartsSangstat Medical Corp. · 19991 recall
  • K973203Thymostat Elisa for the Detection of Human Igg,M and a Anti-Rabbit Igg AntibodiesSangstat Medical Corp. · 1998
  • K980109Cyclotech Cyclosporine Oral Solutions DispenserSangstat Medical Corp. · 1998

All 3 as Sangstat Medical Corp. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K991594Brand Name: Celsior Cold Storage Solution Product Name: Celsior Cold Storage Solution…Mar 13, 2025Class II