510(k) Report

510(k) · Cleared

Cleared

Preassembled Surgical Wash Set

K103202510(k) SpecialCleared Nov 23, 201022-day reviewClass II21 CFR 868.5830

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

Sorin Group Italia S.R.L. · CAC Apparatus, Autotransfusion

Cleared on Nov 23, 2010 as substantially equivalent to K872161 (Shiley, Inc., 1987) and 3 other predicates after a 22-day review. Its family tree reaches back 4 generations to 1989.

Decided
Nov 23, 2010
Review
22 days
Class
Class II
Product code
CAC
Recalls
None
Predicates
4

Its longest line of descent runs back 4 generations to K884564 (1989). 10 ancestors in all, the oldest K872161 (1987). No later device cites it as a predicate yet.

Other ancestors, by year cleared 1987: 1 other ancestor1999: 1 other ancestor1998: 2 other ancestors1995: 1 other ancestor1991: 1 other ancestorK884564 · Shiley Therapeutic Autotransfusion System-Programm · Shiley, Inc. · 1989K982650 · Autologous Blood Management System (Abms) · Dideco S.P.A. · 1998 · recalledK020647 · Dideco Electa · Dideco S.P.A. · 2002 · recalledK101586 · Xtra Autotransfusion System · Sorin Group Italia S.R.L. · 2010198519901995200020052010
Other ancestors, by generation 1 generation back: 1 other ancestor2 generations back: 5 other ancestors K101586 · Xtra Autotransfusion System · Sorin Group Italia S.R.L. · 2010K020647 · Dideco Electa · Dideco S.P.A. · 2002 · recalledK982650 · Autologous Blood Management System (Abms) · Dideco S.P.A. · 1998 · recalledK884564 · Shiley Therapeutic Autotransfusion System-Programm · Shiley, Inc. · 19890
  1. Root · 4 generations backK884564 Shiley Therapeutic Autotransfusion System-ProgrammShiley, Inc. · 1989
  2. 3 generations backK982650 Autologous Blood Management System (Abms)Dideco S.P.A. · 1998 · Recalled
  3. 2 generations backK020647 Dideco ElectaDideco S.P.A. · 2002 · Recalled
  4. 1 generation backK101586 Xtra Autotransfusion SystemSorin Group Italia S.R.L. · 2010
  5. This deviceK103202 Preassembled Surgical Wash SetSorin Group Italia S.R.L. · 2010
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K884564Shiley Therapeutic Autotransfusion System-ProgrammShiley, Inc.1989—
−3K982650Autologous Blood Management System (Abms)Dideco S.P.A.19982
−2K020647Dideco ElectaDideco S.P.A.20022
−1K101586Xtra Autotransfusion SystemSorin Group Italia S.R.L.2010—
0 (this device)K103202Preassembled Surgical Wash SetSorin Group Italia S.R.L.2010—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198710
199110
199510
199820
199910
FIG. 1 — Lineage of K103202, 1989–2010Source: 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? (4)

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
*K872161Dideco-Shiley Preassembled Surgical Wash Set
Summary page 1
…hing Set for Autotransfusion System CLASSIFICATION NAME: Apparatus, Autotransfus ion UNMODIFIED DEVICE: Preassembled Surgical Wash Set (#K872161) PREDICATE DEVICE : Preassembled Surgical Wash Set for Dideco Electa Autotra…
Shiley, Inc.1987—
*K020647Dideco Electa
Summary page 1
…cal Wash Set (#K872161) PREDICATE DEVICE : Preassembled Surgical Wash Set for Dideco Electa Autotransfusion System (#K020647). Preassembled Surgical Wash Set for ABMS/Compact Advanc…
Dideco S.P.A.20022
*K982650Autologous Blood Management System (Abms)
Summary page 1
…Preassembled Surgical Wash Set for ABMS/Compact Advanced Autotransfus ion Equipment (#K982650). Bowl Set for XTRA Autotransfusion System (#K1 01586). D…
Dideco S.P.A.19982
*K101586Xtra Autotransfusion System
Summary page 1
…Equipment (#K982650). Bowl Set for XTRA Autotransfusion System (#K1 01586). DEVICE DESCRIPTION: The Preassembled Surgical Wash Set is sterile, non-pyrogenic…
Sorin Group Italia S.R.L.2010—

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?

  • The line of descent spans 21 years and passes through 3 companies; a new generation was cleared every 8.1 years on median.
  • 2 of the 10 ancestors have a recall of any class.

How does its category compare?

All CAC devices

CAC Apparatus, Autotransfusion: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

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 Preassembled Surgical Wash Set is intended for use with specific Autotransfusion machines which are identified on the primary label. It contains the basic components necessary to process blood collected during open heart or other surgical procedures for autotransfusion.

Indications for use as stated in the FDA summary.

More from Sorin Group Italia S.R.L.

63 FDA decisions under this applicant name. See the company

  • K263092Dual Stage Venous CannulaeSorin Group Italia S.R.L. · 2026
  • K262052Tri Stage Venous CannulaeSorin Group Italia S.R.L. · 2026
  • K253671Dual Stage Venous CannulaeSorin Group Italia S.R.L. · 2026
  • K251783Inspire HCR and HCR DUAL cardiotomy reservoirsSorin Group Italia S.R.L. · 2025
  • K253616ProtekDilate Vascular Access KitSorin Group Italia S.R.L. · 2025

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/K103202 · printed Nov 6, 2026

Cite this page

510(k) Report. “K103202: Preassembled Surgical Wash Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103202

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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