510(k) · Cleared
Recalled · Class II · 2018Orthopat Advance Perioperative Autotransfusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Haemonetics Corp. · CAC Apparatus, Autotransfusion
Cleared on Oct 25, 2012 as substantially equivalent to K992723 (Transfusion Technologies Corp., 1999) after a 90-day review. Its family tree reaches back 2 generations to 1991. It has been recalled once.
- Decided
- Oct 25, 2012
- Review
- 90 days
- Class
- Class II
- Product code
- CAC
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K910238 (1991). No later device cites it as a predicate yet.
- Root · 2 generations backK910238 Portable Auto Transfusion System 500Electromedics, Inc. · 1991
- 1 generation backK992723 Orthopedic Perioperative Autotransfusion (Orthopat) SystemTransfusion Technologies Corp. · 1999 · Recalled
- This deviceK122262 Orthopat Advance Perioperative Autotransfusion SystemHaemonetics Corp. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K910238 | Portable Auto Transfusion System 500 | Electromedics, Inc. | 1991 | — |
| −1 | K992723 | Orthopedic Perioperative Autotransfusion (Orthopat) System | Transfusion Technologies Corp. | 1999 | 2 |
| 0 (this device) | K122262 | Orthopat Advance Perioperative Autotransfusion System | Haemonetics Corp. | 2012 | — |
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
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- #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 |
|---|---|---|---|
| * | K992723 | Orthopedic Perioperative Autotransfusion (Orthopat) SystemSummary page 3…sion System is an evolution of the OrthoPAT Perioperative Autotransfusion System. The OrthoPAT Perioiperative Autotransfusion System was most recently cleared via 510(k) K992723 on October 18, 1999. The OrthoPAT advance System is designed to perform the same types of procedures as the previously-cleared Or… | 1999 |
What descends from it?
No later submission names this one as a predicate yet.
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-2951-2018 | 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. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 3 companies; a new generation was cleared every 13.0 years on median.
- 1 of the 2 ancestors has a recall of any class.
How does its category compare?
All CAC devicesCAC Apparatus, Autotransfusion: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
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 Haemonetics OrthoPAT advance (Orthopedic Perioperative Autotransfusion) System is indicated for use to salvage Red Blood Cells (RBCs) from blood lost intraoperatively and postoperatively during surgical procedures where the expected rate of processing of salvaged blood and 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…
Read the full statement (160 words)
The Haemonetics OrthoPAT advance (Orthopedic Perioperative Autotransfusion) System is indicated for use to salvage Red Blood Cells (RBCs) from blood lost intraoperatively and postoperatively during surgical procedures where the expected rate of processing of salvaged blood and 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 as stated in the FDA summary.
https://510kreport.com/device/K122262 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122262: Orthopat Advance Perioperative Autotransfusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122262
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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