510(k) Report

FDA applicant

Transfusion Technologies Corp.

Natick, MA3 decisions1997–19992 recalls

FDA records 3 decisions for Transfusion Technologies Corp. (Natick, MA) from 1997 to 1999: 3 510(k) clearances. All are in product code CAC (Apparatus, Autotransfusion). Its devices cite 7 predicates, 0 of them its own earlier devices. 2 recalls are linked to its devices.

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

FIG. A — Illustration, anesthesiology panel, where it files most

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

FDA decisions per year

No FDA decision for Transfusion Technologies Corp. since 2007.

Recalls per year

1in 2018

2011: 12018: 1
2007high 1 (2011) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Transfusion Technologies 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?

  • CACApparatus, Autotransfusion3decisions

Whose devices does it build on?

Its devices cite 7 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.

  • K992723Orthopedic Perioperative Autotransfusion (Orthopat) SystemTransfusion Technologies Corp. · 19991cites it

What has FDA decided for it lately?

  • K992723Orthopedic Perioperative Autotransfusion (Orthopat) SystemTransfusion Technologies Corp. · 19992 recalls
  • K982660Orthopedic Perioperative Autotransfusion (Orthopat) SystemTransfusion Technologies Corp. · 1999
  • K962475Orthopedic Perioperative Autotransfusion (Orthopat) SystemTransfusion Technologies Corp. · 1997

All 3 as Transfusion Technologies Corp. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K992723Haemonetics OrthoPAT System-Integrated Set. Product Code: 1150H-00 OrthoPAT orthopedic…Jul 13, 2018Class II
  • K992723Haemonetics OrthoPAT -Orthopedic Perioperative Autotransfusion System US Only…Apr 29, 2011