510(k) · Cleared
ClearedHaemonetics LN 193 Disposable Set, for Use with the Haemonetics Cellsever Haemolite 2 Family of Autologous Blood Recover
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Haemonetics Corp. · CAC Apparatus, Autotransfusion
Cleared on Nov 18, 1999 as substantially equivalent to K883934 (Haemonetics Corp., 1988) after a 27-day review. Its family tree reaches back 1 generation to 1988.
- Decided
- Nov 18, 1999
- Review
- 27 days
- Class
- Class II
- Product code
- CAC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K883934 (1988). No later device cites it as a predicate yet.
- Root · 1 generation backK883934 Cell Saver Haemolite B Auto. Blood Recovery SystemHaemonetics Corp. · 1988
- This deviceK993581 Haemonetics LN 193 Disposable Set, for Use with the Haemonetics…Haemonetics Corp. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K883934 | Cell Saver Haemolite B Auto. Blood Recovery System | Haemonetics Corp. | 1988 | — |
| 0 (this device) | K993581 | Haemonetics LN 193 Disposable Set, for Use with the Haemonetics Cellsever… | Haemonetics Corp. | 1999 | — |
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 |
|---|---|---|---|
| * | K883934 | Cell Saver Haemolite B Auto. Blood Recovery SystemSummary page 1…ponents (21 CFR 864.9100) Common Name: LN193, HaemolLite® Autotransfusion Disposable Set Predicate Devices: Predicate Device Reference LN 163 — Haemonetics Cell Saver K883934 HaemolL.ite 2 Disposable Set (200 mL bowl with diverter)® DEVICE DESCRIPTION Modification to an Existing Device This Special 5… | 1988 |
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?
- Its one ancestor has no 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?
To be used with the Haemonetics Cell Saver Haemolite 2 family of autologous blood recovery systems to collect, concentrate, and wash red blood cells from diluted intraoperative and post-operative sned blood for autotransfusion.
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/K993581 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993581: Haemonetics LN 193 Disposable Set, for Use with the Haemonetics Cellsever Haemolite 2 Family of Autologous Blood Recover.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993581
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