510(k) · Cleared
ClearedProCell Surgical Sponge-Blood Recovery Unit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Procell Surgical, Inc. · CAC Apparatus, Autotransfusion
Cleared on Jun 1, 2020 as substantially equivalent to K140205 (Teleflexmedical, Inc., 2014) after a 180-day review. Its family tree reaches back 6 generations to 1980.
- Decided
- Jun 1, 2020
- Review
- 180 days
- Class
- Class II
- Product code
- CAC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K801043 (1980). 13 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK801043 E-Vax Chest Drainage SystemCardio Surgical Concepts, Inc. · 1980
- 5 generations backK963850 Pleur-Evac Sahara Plus Model S-1150 Continuous Reinfusion…Deknatel, Inc. · 1997
- 4 generations backK031554 S-1150 Pleur-Evac Sahara Plus Continuous Reinfusion Autotransfusion…Genzyme Biosurgery · 2003
- 3 generations backK120953 Pleur-Evac Sahara Plus Continous Reinfusion Autotransfusion SystemTlelflex Medical, Inc. · 2012
- 2 generations backK130043 Pleur-Evac Sahara Plus Continuous Reinfusion Autotransfusion SystemTeleflexmedical, Inc. · 2013
- 1 generation backK140205 Pleur-Evac Sahara Plus Continuous Reinfusion and Autotransfusion…Teleflexmedical, Inc. · 2014 · Recalled
- This deviceK193361 ProCell Surgical Sponge-Blood Recovery UnitProcell Surgical, Inc. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K801043 | E-Vax Chest Drainage System | Cardio Surgical Concepts, Inc. | 1980 | — |
| −5 | K963850 | Pleur-Evac Sahara Plus Model S-1150 Continuous Reinfusion Autotransfusion System | Deknatel, Inc. | 1997 | — |
| −4 | K031554 | S-1150 Pleur-Evac Sahara Plus Continuous Reinfusion Autotransfusion System | Genzyme Biosurgery | 2003 | — |
| −3 | K120953 | Pleur-Evac Sahara Plus Continous Reinfusion Autotransfusion System | Tlelflex Medical, Inc. | 2012 | — |
| −2 | K130043 | Pleur-Evac Sahara Plus Continuous Reinfusion Autotransfusion System | Teleflexmedical, Inc. | 2013 | — |
| −1 | K140205 | Pleur-Evac Sahara Plus Continuous Reinfusion and Autotransfusion System | Teleflexmedical, Inc. | 2014 | 1 |
| 0 (this device) | K193361 | ProCell Surgical Sponge-Blood Recovery Unit | Procell Surgical, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1985 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 2 | 0 |
| 1996 | 1 | 0 |
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 K240426 Aventus Clot Management Systemscore 11.2 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K140205 | Pleur-Evac Sahara Plus Continuous Reinfusion and Autotransfusion SystemSummary page 4…868.5830 Class: II Product Code: CAC Review Panel: Anesthesiology C) Predicate: K140205 Teleflex Medical, Inc. Pleur-Evac Sahara Plus Continuous Reinfusion and Autotransfusion System… | 2014 |
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 40 years and passes through 6 companies; a new generation was cleared every 6.3 years on median.
- 2 of the 13 ancestors have a recall of any class.
How does its category compare?
All CAC devicesCAC Apparatus, Autotransfusion: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · CAC
3in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · CAC
91in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CAC
7in 2023
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · CAC
128in 2025
MAUDE reports naming product code CAC, 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 | 0 | — | 1 | 35 |
| 2008 | 1 | — | 5 | 12 |
| 2009 | 0 | — | 25 | 68 |
| 2010 | 4 | 123 | 3 | 115 |
| 2011 | 2 | — | 3 | 939 |
| 2012 | 3 | 90 | 0 | 249 |
| 2013 | 1 | — | 9 | 153 |
| 2014 | 3 | 269 | 0 | 90 |
| 2015 | 0 | — | 0 | 87 |
| 2016 | 2 | — | 0 | 73 |
| 2017 | 1 | — | 2 | 88 |
| 2018 | 2 | — | 2 | 87 |
| 2019 | 1 | — | 23 | 64 |
| 2020 | 1 | — | 0 | 108 |
| 2021 | 4 | 155 | 0 | 73 |
| 2022 | 1 | — | 0 | 65 |
| 2023 | 2 | — | 7 (2) | 39 |
| 2024 | 3 | 91 | 0 | 129 |
| 2025 | 0 | — | 0 | 128 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
ProCell™ facilitates the extraction of blood from surgical sponges as a preliminary step in the process of intraoperative autotransfusion or IAT.
ProCell™ functions as a blood collection device only and does not filter or otherwise process the blood recovered. As an accessory to IAT, it is used in conjunction with standard IAT equipment which processes the blood retrieved from ProCell™ prior to reinfusion into the patient (autologous blood transfusion).
Designed for ease-of-use directly on the surgical instrument table, the disposable ProCell™ can be used repeatedly during a surgical case and provides an alternative to other sponge-blood recovery methods including hand-wringing.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K193361 · printed Nov 5, 2026
Cite this page
510(k) Report. “K193361: ProCell Surgical Sponge-Blood Recovery Unit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K193361
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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