Orthopedic Perioperative Autotransfusion (Orthopat) System
by Transfusion Technologies Corp. 3 variants
510(k) K992723
Active
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK992723 | Date18 Oct 1999 | StatusActive |
Recalls
-
- Terminated Z-2950-2018
OrthoPAT reservoirs are missing the cannula inside the reservoirs. The absence of this cannula prevents the emptying of blood from the reservoirs. The inability to empty the reservoir means that the collected blood cannot be processed.
-
- Terminated Z-2420-2011
2 Models Model 1: OrthoPAT devices with no centrifuge drain spill containment system may have potential for fluid contamination leading to potential spark or smoke may occur are recalled Model 2: OrthoPat equipped with a spill collection drainage system updated with revised Instructions for Use and Quick reference Guide Addendum
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- CAC
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.5830
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 21 Sep 2026
The Orthopedic Perioperative Autotransfusion (Orthopat) System is an apparatus for autotransfusion. It is classified as a Class II medical device under regulation number 868.5830.
The system received FDA 510(k) clearance (K992723) on October 18, 1999, as substantially equivalent to a predicate device. It is manufactured by Transfusion Technologies Corp. and is intended for use in anesthesiology settings.
Other devices from Transfusion Technologies Corp.
Questions
AI-generated answers, 21 Sep 2026
What is the Orthopedic Perioperative Autotransfusion (Orthopat) System used for?
The Orthopat System is an apparatus designed for autotransfusion, which involves collecting, processing, and reinfusing a patient's own blood during or after surgery. It is intended for use in anesthesiology settings to reduce the need for allogeneic blood transfusions by recycling the patient's blood.
How is the Orthopat System supplied and is it reusable?
The Orthopat System is supplied as a reusable apparatus for autotransfusion. It is not a single-use device; instead, it is designed for repeated use in clinical settings after appropriate cleaning and reprocessing according to the manufacturer's instructions, as it is classified as a durable medical device under Class II regulations.
What regulatory pathway was used for the Orthopat System and when was it cleared?
The Orthopat System received FDA 510(k) clearance through the traditional pathway, with clearance granted on October 18, 1999, under K992723. It was determined to be substantially equivalent to a predicate device, which allowed it to be marketed for its intended use in autotransfusion within anesthesiology settings.