510(k) · Cleared
ClearedHaemocell System 350 or S350
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Haemocell Plc · CAC Apparatus, Autotransfusion
Cleared on Dec 10, 1996 as substantially equivalent to K914053 (Stryker Corp., 1992) and 1 other predicate after a 292-day review. Its family tree reaches back 1 generation to 1986.
- Decided
- Dec 10, 1996
- Review
- 292 days
- Class
- Class II
- Product code
- CAC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K861677 (1986). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK861677 Pharmaseal Medi-Vac Intra-Oper. Autotransfus. KitAmerican Pharmaseal Div. Ahsc · 1986
- This deviceK960734 Haemocell System 350 or S350Haemocell Plc · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K861677 | Pharmaseal Medi-Vac Intra-Oper. Autotransfus. Kit | American Pharmaseal Div. Ahsc | 1986 | — |
| 0 (this device) | K960734 | Haemocell System 350 or S350 | Haemocell Plc | 1996 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 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? (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 |
|---|---|---|---|
| * | K914053 | System 350Summary page 2…e which is the subject of this submission is equivalent to the Haemocell System 350 granted marketing clearance following submission of a 510(k) document (control number K914053B) and to the Baxter Medi-Vac ATS granted marketing clearance following the submission of a 510(k) document (control number K86167… | 1992 |
| * | K861677 | Pharmaseal Medi-Vac Intra-Oper. Autotransfus. KitSummary page 2…n of a 510(k) document (control number K914053B) and to the Baxter Medi-Vac ATS granted marketing clearance following the submission of a 510(k) document (control number K861677). Description of the Device 2.1 Device Fungii The Haemocell System 350 is a device designed for collecting and reinfusing a p… | 1986 |
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 2 ancestors has a recall.
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 Haemocell System 350 is an autologous transfusion system designed to collect blood during or after an elective or emergency surgical procedure, filter the blood, process as required by the physician, and reinfuse the autologous blood.
The Haemocell System 350 is designed to be used in accordance with the American Association of Blood Banks, Guidelines for Blood Salvage and Reinfusion in Surgery and Trauma (1993). No change to the intended use of the System 350 is proposed as compared to the predicate devices.
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/K960734 · printed Nov 6, 2026
Cite this page
510(k) Report. “K960734: Haemocell System 350 or S350.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K960734
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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