510(k) · Cleared
ClearedHaemonetics Therapeutic Plasma Exchange Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Haemonetics Corp. · LKN Separator, Automated, Blood Cell And Plasma, Therapeutic
Cleared on Jun 4, 1996 as substantially equivalent to K900105 (Cobe Laboratories, Inc., 1991) after a 302-day review. Its family tree reaches back 1 generation to 1991.
- Decided
- Jun 4, 1996
- Review
- 302 days
- Class
- Class U
- Product code
- LKN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K900105 (1991). No later device cites it as a predicate yet.
- Root · 1 generation backK900105 Cobe Spectra Blood Component Separator TherapeuticCobe Laboratories, Inc. · 1991
- This deviceK953681 Haemonetics Therapeutic Plasma Exchange SetHaemonetics Corp. · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K900105 | Cobe Spectra Blood Component Separator Therapeutic | Cobe Laboratories, Inc. | 1991 | — |
| 0 (this device) | K953681 | Haemonetics Therapeutic Plasma Exchange Set | Haemonetics Corp. | 1996 | — |
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 LKN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K900105 | Cobe Spectra Blood Component Separator TherapeuticSummary page 1…t Predicate Device MCS/MCS+ COBE Spectra™ (MCS List No. 7000) (MCS+ List Nos. 8100 and 9000) Single Needle Access Accessory System for Therapeutic Plasma Exchange (BK900105) List Nos. 780 and 980 Therapeutic Plasma Exchange Sets (225 ml bowl) COBE Single Needle Access disposable set: Blood Tubing S… | 1991 |
| * | — | COBE Spectra™ Named without a submission number |
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.
- 2 other devices also cite its predicate K900105.
How does its category compare?
All LKN devicesLKN Separator, Automated, Blood Cell And Plasma, Therapeutic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LKN
2in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · LKN
195in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LKN
1in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LKN
71in 2025
MAUDE reports naming product code LKN, 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 | 1 | — | 1 | 10 |
| 2008 | 0 | — | 0 | 14 |
| 2009 | 0 | — | 0 | 18 |
| 2010 | 1 | — | 2 | 132 |
| 2011 | 0 | — | 3 | 481 |
| 2012 | 2 | — | 1 | 372 |
| 2013 | 2 | — | 0 | 96 |
| 2014 | 1 | — | 0 | 128 |
| 2015 | 2 | — | 0 | 306 |
| 2016 | 1 | — | 0 | 206 |
| 2017 | 0 | — | 0 | 169 |
| 2018 | 3 | 195 | 0 | 55 |
| 2019 | 2 | — | 0 | 72 |
| 2020 | 0 | — | 0 | 135 |
| 2021 | 0 | — | 0 | 63 |
| 2022 | 0 | — | 0 | 42 |
| 2023 | 0 | — | 0 | 132 |
| 2024 | 0 | — | 0 | 161 |
| 2025 | 0 | — | 0 | 71 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
TPE is performed using the Haemonetics MCS/MCS+ system to remove a significant quantity of platelet poor plasma and replace it with a solution as determined by the attending physician.
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/K953681 · printed Nov 4, 2026
Cite this page
510(k) Report. “K953681: Haemonetics Therapeutic Plasma Exchange Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K953681
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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