# K960993: Pall SQ40S Blood Filter (SQ40S/SQ40ST)

- Pathway: 510(k) (Traditional)
- Applicant: Pall Biomedical Products Co.
- Decided: Apr 22, 1996 after 41 days
- Product code: CAK (Microfilter, Blood Transfusion)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
9 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K022477: Summit Medical LTD Transfusion Filter, Model LF400 & Summit Medical LTD Transfusion Filter with Administration Set (2002), 8 descendants of its own
- K024097: Summit Medical LTD Celltrans Postoperative Autotransfusion Set, Models AB400-10, AB400-12, AB400-14 (2003), 7 descendants of its own
- K210176: FlowSaver Blood Filter (2021), 6 descendants of its own
- K240426: Aventus Clot Management System (2024), 3 descendants of its own
- K253925: Aventus Thrombectomy System (2026), 2 descendants of its own

## Recalls of this device
- Nov 3, 2025 · Class II · Z-1157-2026: Due to products being released for distribution prior to completion of the required quality control release process the sterility assurance cannot be confirmed.

Source page: https://510kreport.com/device/K960993
Methodology: https://510kreport.com/methodology
