510(k) · Cleared
Recalled · Class II · 2018Orthopedic Perioperative Autotransfusion (Orthopat) System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Transfusion Technologies Corp. · CAC Apparatus, Autotransfusion
Cleared on Oct 18, 1999 as substantially equivalent to K910238 (Electromedics, Inc., 1991) after a 66-day review. Its family tree reaches back 1 generation to 1991. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Oct 18, 1999
- Review
- 66 days
- Class
- Class II
- Product code
- CAC
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K910238 (1991). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK910238 Portable Auto Transfusion System 500Electromedics, Inc. · 1991
- This deviceK992723 Orthopedic Perioperative Autotransfusion (Orthopat) SystemTransfusion Technologies Corp. · 1999
- Descendant · cites it directly · 0 of its ownK122262 Orthopat Advance Perioperative Autotransfusion SystemHaemonetics Corp. · 2012 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K122262Orthopat Advance Perioperative Autotransfusion SystemHaemonetics Corp. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K910238 | Portable Auto Transfusion System 500 | Electromedics, Inc. | 1991 | — |
| 0 (this device) | K992723 | Orthopedic Perioperative Autotransfusion (Orthopat) System | Transfusion Technologies Corp. | 1999 | — |
| +1 | K122262 | Orthopat Advance Perioperative Autotransfusion System | Haemonetics Corp. | 2012 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in CAC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new CAC device
- #1 K240426 Aventus Clot Management Systemscore 11.2 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K910238 | Portable Auto Transfusion System 500Summary page 1…on System Predicate Device: The OrthoPAT Perioperative Autotransfusion System is substantially equivalent to the Electromedics PAT 500 Portable Autotransfusion System (K910238). ! OrthoPAT is a registered trademark of Transfusion Technologies Corporation Device Description:- The OrthoPA… | 1991 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K122262 | Orthopat Advance Perioperative Autotransfusion System | 2012 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 13, 2018 | Class II | Z-2950-2018 | Process control | 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. |
| Apr 29, 2011 | Not classified | Z-2420-2011 | Device Design | 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… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All CAC devicesCAC Apparatus, Autotransfusion: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CAC
3in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · CAC
91in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CAC
7in 2023
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · CAC
128in 2025
MAUDE reports naming product code CAC, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 1 | 35 |
| 2008 | 1 | — | 5 | 12 |
| 2009 | 0 | — | 25 | 68 |
| 2010 | 4 | 123 | 3 | 115 |
| 2011 | 2 | — | 3 | 939 |
| 2012 | 3 | 90 | 0 | 249 |
| 2013 | 1 | — | 9 | 153 |
| 2014 | 3 | 269 | 0 | 90 |
| 2015 | 0 | — | 0 | 87 |
| 2016 | 2 | — | 0 | 73 |
| 2017 | 1 | — | 2 | 88 |
| 2018 | 2 | — | 2 | 87 |
| 2019 | 1 | — | 23 | 64 |
| 2020 | 1 | — | 0 | 108 |
| 2021 | 4 | 155 | 0 | 73 |
| 2022 | 1 | — | 0 | 65 |
| 2023 | 2 | — | 7 (2) | 39 |
| 2024 | 3 | 91 | 0 | 129 |
| 2025 | 0 | — | 0 | 128 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The OrthoPAT Perioperative Autotransfusion System is indicated for use to salvage RBCs from blood lost intraoperatively and postoperatively during surgical procedures where the expected rate of processing of salvaged blood ang fluid aspirated from the surgical site is less than or equal to 2 liters per hour. Autotransfusion is indicated for patients who meet at least one of the following criteria: The patient is expected to lose sufficient blood in the…
Read the full statement (149 words)
The OrthoPAT Perioperative Autotransfusion System is indicated for use to salvage RBCs from blood lost intraoperatively and postoperatively during surgical procedures where the expected rate of processing of salvaged blood ang fluid aspirated from the surgical site is less than or equal to 2 liters per hour. Autotransfusion is indicated for patients who meet at least one of the following criteria:
The patient is expected to lose sufficient blood in the perioperative period so as to require RBC transfusion, and autotransfusion will likely reduce or eliminate the need for allogeneic blood transfusion.
Religious beliefs cause the patient to refuse allogeneic transfusion, but accept autologous transfusion.
Compatible allogeneic blood is not available.
The patient is unable to donate sufficient quantities of autologous blood prior to surgery to adequately cover the anticipated transfusion requirement.
The patient or physician prefers perioperative autotransfusion rather than preoperative autologous donation or transfusion of allogeneic blood.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K992723 · printed Nov 5, 2026
Cite this page
510(k) Report. “K992723: Orthopedic Perioperative Autotransfusion (Orthopat) System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K992723
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026