# K951592: Betatrans I and II

- Pathway: 510(k) (Traditional)
- Applicant: Duxbury Scientific, Inc.
- Decided: Mar 4, 1996 after 333 days
- Product code: CAC (Apparatus, Autotransfusion)
- Device class: 2
- Regulation: 21 CFR 868.5830
- Recalls of this device: none
- 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. The FDA summary names its predicate without a number.
- (no number) Stryker® ConstaVac™ Blood Conservation System: named in the summary without a submission number
- (no number) Solcotrans® Plus (Davol®, a division of C.R. Bard, Inc.): named in the summary without a submission number
- (no number) Gish Medical Blood Recovery/Autotransfusion system: named in the summary without a submission number
- (no number) Gish Medical Orthofusor: named in the summary without a submission number
- (no number) Boehringer Laboratories AutoVac: named in the summary without a submission number

## Most influential descendants
- K022489: Summit Medical LTD Celltrans Postoperative Autotransfusion System, Models ABT4510, ABT4512 & ABT4514 (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

## Indications for use
To collect and infuse blood lost by a patient due to orthopaedic surgery..

Source page: https://510kreport.com/device/K951592
Methodology: https://510kreport.com/methodology