510(k) · Cleared
ClearedOrthopedic 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 Mar 30, 1999 as substantially equivalent to K910238 (Electromedics, Inc., 1991) and 2 other predicates after a 243-day review. Its family tree reaches back 1 generation to 1981.
- Decided
- Mar 30, 1999
- Review
- 243 days
- Class
- Class II
- Product code
- CAC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K812355 (1981). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK812355 Ibm 2991 Blood Cell Processor Mod. 1 & 2Intl. Business Machines · 1981
- This deviceK982660 Orthopedic Perioperative Autotransfusion (Orthopat) SystemTransfusion Technologies Corp. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K812355 | Ibm 2991 Blood Cell Processor Mod. 1 & 2 | Intl. Business Machines | 1981 | — |
| 0 (this device) | K982660 | Orthopedic Perioperative Autotransfusion (Orthopat) System | Transfusion Technologies Corp. | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1993 | 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? (3)
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…n System Predicate Devices: The OrthoPAT Perioperative Autotransfusion System is substantially equivalent to the Electromedics PAT 500 Portable Autotransfusion System (K910238), the IBM Model 2991 Blood Cell Processor (K812355), and the Solco-Basle Solcotrans® SI Orthopedic Autotransfusion Set (K913177).… | 1991 |
| * | K812355 | Ibm 2991 Blood Cell Processor Mod. 1 & 2Summary page 1…ative Autotransfusion System is substantially equivalent to the Electromedics PAT 500 Portable Autotransfusion System (K910238), the IBM Model 2991 Blood Cell Processor (K812355), and the Solco-Basle Solcotrans® SI Orthopedic Autotransfusion Set (K913177). ! OrthoPAT is a trademark of Transfusion Technolo… | 1981 |
| * | K913177 | Solcotrans Orthopaedic Drainage/Reinfusion SystemSummary page 1…PAT 500 Portable Autotransfusion System (K910238), the IBM Model 2991 Blood Cell Processor (K812355), and the Solco-Basle Solcotrans® SI Orthopedic Autotransfusion Set (K913177). ! OrthoPAT is a trademark of Transfusion Technologies Corporation Device Description: The OrthoPAT™ system co… | 1993 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 3 ancestors has a recall.
- 2 other devices also cite its predicate K910238.
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 Orthopedic Perioperative Autotransfusion system is indicated for use to salvage RBCs from blood lost intraoperatively and postoperatively during orthopedic surgery procedures. Appropriate orthopedic procedures include joint replacement (primary and revision), and spinal fusion and instrumentation. 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 (139 words)
The OrthoPAT Orthopedic Perioperative Autotransfusion system is indicated for use to salvage RBCs from blood lost intraoperatively and postoperatively during orthopedic surgery procedures. Appropriate orthopedic procedures include joint replacement (primary and revision), and spinal fusion and instrumentation. 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/K982660 · printed Nov 4, 2026
Cite this page
510(k) Report. “K982660: Orthopedic Perioperative Autotransfusion (Orthopat) System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982660
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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