510(k) Report

510(k) · Cleared

Recalled · 2006

Autologous Blood Management System (Abms)

K982650510(k) AbbreviatedCleared Dec 16, 1998139-day reviewClass II21 CFR 868.5830Recalls 2

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Dideco S.P.A. · CAC Apparatus, Autotransfusion

Cleared on Dec 16, 1998 as substantially equivalent to K884564 (Shiley, Inc., 1989) and 4 other predicates after a 139-day review. Its family tree reaches back 1 generation to 1989. 8 later devices descend from it. It has been recalled 2 times.

Decided
Dec 16, 1998
Review
139 days
Class
Class II
Product code
CAC
Recalls
2
Predicates
5

Its longest line of descent runs back 1 generation to K884564 (1989). 5 ancestors in all. 8 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1998: 2 other ancestors1995: 1 other ancestor1991: 1 other ancestor2002: 1 descendant cleared2006: 1 descendant cleared2010: 2 descendants cleared2024: 2 descendants cleared2011: 1 descendant cleared2014: 1 descendant clearedK884564 · Shiley Therapeutic Autotransfusion System-Programm · Shiley, Inc. · 19891990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors 1 generation forward: 3 descendants2 generations forward: 1 descendant3 generations forward: 3 descendants4 generations forward: 1 descendant K884564 · Shiley Therapeutic Autotransfusion System-Programm · Shiley, Inc. · 19890
  1. Root · 1 generation backK884564 Shiley Therapeutic Autotransfusion System-ProgrammShiley, Inc. · 1989
  2. This deviceK982650 Autologous Blood Management System (Abms)Dideco S.P.A. · 1998
  3. Descendant · cites it directly · 7 of its ownK020647 Dideco ElectaDideco S.P.A. · 2002 · Recalled
  4. Descendant · 2 generations on · 5 of its ownK101586 Xtra Autotransfusion SystemSorin Group Italia S.R.L. · 2010
  5. Descendant · 3 generations on · 1 of its ownK112245 XTRASorin Group Italia S.R.L. · 2011
  6. Descendant · 3 generations on · 0 of its ownK241236 XTRA Collection sets; XTRA Sequestration set XSorin Group Italia S.R.L. · 2024
  7. Descendant · 3 generations on · 0 of its ownK240584 XTRA Autotransfusion System (with XTRA Bowl sets)Sorin Group Italia S.R.L. · 2024

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2002: 12006: 12010: 22011: 12014: 12024: 2
2002high 2 (2010) · low 0 (2003)2026

Most influential descendants

Showing 5 of 8 · See all
  • K020647Dideco ElectaDideco S.P.A. · 2002 · cites it directly7descendants
  • K101586Xtra Autotransfusion SystemSorin Group Italia S.R.L. · 2010 · 2 generations on5descendants
  • K112245XTRASorin Group Italia S.R.L. · 2011 · 3 generations on1descendant
  • K241236XTRA Collection sets; XTRA Sequestration set XSorin Group Italia S.R.L. · 2024 · 3 generations on0descendants
  • K240584XTRA Autotransfusion System (with XTRA Bowl sets)Sorin Group Italia S.R.L. · 2024 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K884564Shiley Therapeutic Autotransfusion System-ProgrammShiley, Inc.1989—
0 (this device)K982650Autologous Blood Management System (Abms)Dideco S.P.A.1998—
+1K020647Dideco ElectaDideco S.P.A.20022
+2K101586Xtra Autotransfusion SystemSorin Group Italia S.R.L.2010—
+3K112245XTRASorin Group Italia S.R.L.2011—
+3K241236XTRA Collection sets; XTRA Sequestration set XSorin Group Italia S.R.L.2024—
+3K240584XTRA Autotransfusion System (with XTRA Bowl sets)Sorin Group Italia S.R.L.2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199110
199510
199820

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200610
201020
201110
201410
202420
FIG. 1 — Lineage of K982650, 1989–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K240426 Aventus Clot Management Systemscore 11.2 · 4 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (6)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K884564Shiley Therapeutic Autotransfusion System-Programm
Summary page 2
…y Name: Autologous Blood Management System (ABMS) Common/Usual Name: Autotransfusion Device Classification Names: Autotransfusion Apparatus 3. PREDICATE DEVICES STAT-P K884564 Compact K910991 (under the name Shiley Therapeutic Autotransfusion System) Compact-A K940519 K963758 K963759 AT-1000 K Number c…
Shiley, Inc.1989—
*K910991Shiley Therapeutic Autotransfusion System
Summary page 2
…us Blood Management System (ABMS) Common/Usual Name: Autotransfusion Device Classification Names: Autotransfusion Apparatus 3. PREDICATE DEVICES STAT-P K884564 Compact K910991 (under the name Shiley Therapeutic Autotransfusion System) Compact-A K940519 K963758 K963759 AT-1000 K Number could not be iden…
Shiley, Inc.1991—
*K940519Dideco Compact-a Autotransfusion System
Summary page 2
…assification Names: Autotransfusion Apparatus 3. PREDICATE DEVICES STAT-P K884564 Compact K910991 (under the name Shiley Therapeutic Autotransfusion System) Compact-A K940519 K963758 K963759 AT-1000 K Number could not be identified 4, INTENDED USE The ABMS is indicated for intraoperative and postoper…
Dideco1995—
*K963758Code 150 Blood Component Collection Set and with Direct Draw Line
Summary page 2
…tion Names: Autotransfusion Apparatus 3. PREDICATE DEVICES STAT-P K884564 Compact K910991 (under the name Shiley Therapeutic Autotransfusion System) Compact-A K940519 K963758 K963759 AT-1000 K Number could not be identified 4, INTENDED USE The ABMS is indicated for intraoperative and postoperative re…
Sorin Biomedical, Inc.1998—
*K963759Dideco Compact-a and Compact-M Autotransfusion Systems
Summary page 2
…es: Autotransfusion Apparatus 3. PREDICATE DEVICES STAT-P K884564 Compact K910991 (under the name Shiley Therapeutic Autotransfusion System) Compact-A K940519 K963758 K963759 AT-1000 K Number could not be identified 4, INTENDED USE The ABMS is indicated for intraoperative and postoperative recovery o…
Sorin Biomedical, Inc.1998—
*—AT-1000
Named without a submission number
—

What descends from it? (8)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K020647Dideco ElectaDideco S.P.A.20027
K103202Preassembled Surgical Wash SetSorin Group Italia S.R.L.20100
K060482Cytori Celution Cell Concentration DeviceCytori Therapeutics, Inc.20060

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Aug 4, 2006Not classifiedZ-1490-06OtherForeign particles-manufacturing error may lead to abrasion of bowl seal in blood recovery sets, possibly causing particles in the blood.
Aug 4, 2006Not classifiedZ-1488-06OtherForeign particles-manufacturing error may lead to abrasion of bowl seal in blood recovery sets, possibly causing particles in the blood.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • None of the 5 ancestors has a recall.
  • Of its descendants, K020647 (Dideco S.P.A., 2002) has gone furthest, with 7 descendants of its own.

How does its category compare?

All CAC devices

CAC Apparatus, Autotransfusion: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CAC

3in 2024

2008: 12010: 42011: 22012: 32013: 12014: 32016: 22017: 12018: 22019: 12020: 12021: 42022: 12023: 22024: 3
2007high 4 (2010) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CAC

91in 2024

2010: 123 days median2012: 90 days median2014: 269 days median2021: 155 days median2024: 91 days median
2007high 269 (2014) · low 90 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · CAC

7in 2023

2007: 12008: 52009: 252010: 32011: 32013: 92017: 22018: 22019: 232023: 7, 2 Class I
2007high 25 (2009) · low 0 (2012)2026

Class I (2 since 2007) Class II/III not classified

Adverse event reports per year · CAC

128in 2025

2007: 352008: 122009: 682010: 1152011: 9392012: 2492013: 1532014: 902015: 872016: 732017: 882018: 872019: 642020: 1082021: 732022: 652023: 392024: 1292025: 128
2007high 939 (2011) · low 12 (2008)2025

MAUDE reports naming product code CAC, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—135
20081—512
20090—2568
201041233115
20112—3939
20123900249
20131—9153
20143269090
20150—087
20162—073
20171—288
20182—287
20191—2364
20201—0108
20214155073
20221—065
20232—7 (2)39
20243910129
20250—0128
20260—0—

What is it indicated for?

The ABMS is indicated for intraoperative recovery of blood, washing of blood collected in the post-operative period, and pre-operative sequestration (with indirect and direct patient connection). Typical clinical applications of autotransfusion include the following surgical specialties: Cardiovascular, Orthopedics, Thoracic, Transplant Surgery, Emergency (Trauma), Neurosurgery, Obstetrics and gynecology, Urology.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Dideco S.P.A.

22 FDA decisions under this applicant name. See the company

  • K041061D731 Micro 20 and D733 Micro 40 Pediatric Arterial FiltersDideco S.P.A. · 2004
  • K033323D 903 Avant Adult Hollow Fiber Oxygenator and D 903 Avant 2 PH.I.S.I.O. Adult Hollow Fiber Oxygenator with…Dideco S.P.A. · 20041 recall
  • K033987D735 Micro 20 and D736 Micro 40 Newborn-Infant Arterial FiltersDideco S.P.A. · 2004
  • K033714MVR 1200 PC: Sorin Monolyth Venous Reservoir 1200 PC with Phosphorylcholine CoatingDideco S.P.A. · 2003
  • K032040Ideal Mimesys System with Integrated Venous Air Removal, Centrifugal Blood Pump, Pump Bracket, Adult…Dideco S.P.A. · 20031 recall

Recent decisions in CAC

The CAC category page

  • K241236XTRA Collection sets; XTRA Sequestration set XSorin Group Italia S.R.L. · 2024
  • K240426Aventus Clot Management SystemInquis Medical · 2024
  • K240584XTRA Autotransfusion System (with XTRA Bowl sets)Sorin Group Italia S.R.L. · 2024
  • K231782FlowSaver Blood Return System (80-101)Inari Medical, Inc. · 2023
  • K221483FlowSaver Blood Return SystemInari Medical, Inc. · 2023

https://510kreport.com/device/K982650 · printed Nov 4, 2026

Cite this page

510(k) Report. “K982650: Autologous Blood Management System (Abms).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982650

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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