510(k) · Cleared
ClearedCode 150 Blood Component Collection Set and with Direct Draw Line
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sorin Biomedical, Inc. · CAC Apparatus, Autotransfusion
Cleared on Feb 20, 1998 after a 520-day review. The FDA summary names its predicate without a number. 9 later devices descend from it.
- Decided
- Feb 20, 1998
- Review
- 520 days
- Class
- Class II
- Product code
- CAC
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 1 citing it directly.
- This deviceK963758 Code 150 Blood Component Collection Set and with Direct Draw LineSorin Biomedical, Inc. · 1998
- Descendant · cites it directly · 8 of its ownK982650 Autologous Blood Management System (Abms)Dideco S.P.A. · 1998 · Recalled
- Descendant · 2 generations on · 7 of its ownK020647 Dideco ElectaDideco S.P.A. · 2002 · Recalled
- Descendant · 3 generations on · 5 of its ownK101586 Xtra Autotransfusion SystemSorin Group Italia S.R.L. · 2010
- Descendant · 4 generations on · 1 of its ownK112245 XTRASorin Group Italia S.R.L. · 2011
- Descendant · 4 generations on · 0 of its ownK241236 XTRA Collection sets; XTRA Sequestration set XSorin Group Italia S.R.L. · 2024
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K982650Autologous Blood Management System (Abms)Dideco S.P.A. · 1998 · cites it directly8descendants
- K020647Dideco ElectaDideco S.P.A. · 2002 · 2 generations on7descendants
- K101586Xtra Autotransfusion SystemSorin Group Italia S.R.L. · 2010 · 3 generations on5descendants
- K112245XTRASorin Group Italia S.R.L. · 2011 · 4 generations on1descendant
- K241236XTRA Collection sets; XTRA Sequestration set XSorin Group Italia S.R.L. · 2024 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K963758 | Code 150 Blood Component Collection Set and with Direct Draw Line | Sorin Biomedical, Inc. | 1998 | — |
| +1 | K982650 | Autologous Blood Management System (Abms) | Dideco S.P.A. | 1998 | 2 |
| +2 | K020647 | Dideco Electa | Dideco S.P.A. | 2002 | 2 |
| +3 | K101586 | Xtra Autotransfusion System | Sorin Group Italia S.R.L. | 2010 | — |
| +4 | K112245 | XTRA | Sorin Group Italia S.R.L. | 2011 | — |
| +4 | K241236 | XTRA Collection sets; XTRA Sequestration set X | Sorin Group Italia S.R.L. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2024 | 2 | 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? (2)
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 |
|---|---|---|---|
| * | — | Electromedics Plasma Sequestration Set Named without a submission number | |
| * | — | Electromedics AT-1000 Sequestration Set Named without a submission number |
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K982650 | Autologous Blood Management System (Abms) | 1998 | 8 |
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?
- Of its descendants, K982650 (Dideco S.P.A., 1998) has gone furthest, with 8 descendants of its own.
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?
Code 150 Blood Component Collection Set is intended for separation of Platelet-Poor Plasma (PPP) and Platelet-Rich Plasma (PRP) from whole blood collected into transfer bags. Code 151 Blood Component Set with Direct Draw Line is intended for separation of Platelet-Poor Plasma (PPP) and Platelet-Rich Plasma (PRP) from whole blood collected from directly the patient. The process of PRP/PPP is to be performed in the immediate preoperative period, prior to…
Read the full statement (122 words)
Code 150 Blood Component Collection Set is intended for separation of Platelet-Poor Plasma (PPP) and Platelet-Rich Plasma (PRP) from whole blood collected into transfer bags.
Code 151 Blood Component Set with Direct Draw Line is intended for separation of Platelet-Poor Plasma (PPP) and Platelet-Rich Plasma (PRP) from whole blood collected from directly the patient.
The process of PRP/PPP is to be performed in the immediate preoperative period, prior to the surgical procedure and before the establishment of cardiopulmonary bypass. The collected PRP/PPP shall be administered during or after the operation to aid in the normalization of the patient's hemocoagulative state.
The Electronmedics PRP/PPP Sequestration Kits are indicated for the same use as the Code 150 and Code 151 Blood Component Collection Sets.
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/K963758 · printed Nov 4, 2026
Cite this page
510(k) Report. “K963758: Code 150 Blood Component Collection Set and with Direct Draw Line.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K963758
Report an extraction error
Are you the manufacturer?
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