510(k) · Cleared
ClearedOrwell Fluid Collection and Disposal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardinalhealth · JCX Apparatus, Suction, Ward Use, Portable, Ac-Powered
Cleared on Apr 30, 2008 as substantially equivalent to K012991 (Stryker Instruments, 2001) and 1 other predicate after a 35-day review. Its family tree reaches back 4 generations to 1983. 1 of the 10 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Apr 30, 2008
- Review
- 35 days
- Class
- Class II
- Product code
- JCX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K832520 (1983). 8 ancestors in all. 1 later device descends from it, 1 citing it directly. 1 of the 10 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK832520 Suction TipsWells Johnson Co. · 1983
- 3 generations backK973268 Microaire Power Aspiration Device Pad SystemMicroaire Surgical Instruments, Inc. · 1997 · Recalled
- 2 generations backK984363 XPS Tissue Aspiration System, XPS Straightshot or Model 2000…Xomed, Inc. · 1999
- 1 generation backK040239 Supraflow ConsoleNeomedix Corp. · 2004 · Recalled
- This deviceK080845 Orwell Fluid Collection and Disposal SystemCardinalhealth · 2008
- Descendant · cites it directly · 0 of its ownK090759 Biodrain Streamway Fluid Management SystemBiodrain Medical, Inc. · 2009
Class I recalls in this family
- K012991 Neptune Waste Management Ststemdirect predicate · 2001
Most influential descendants
Showing 1 of 1 · See all- K090759Biodrain Streamway Fluid Management SystemBiodrain Medical, Inc. · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K832520 | Suction Tips | Wells Johnson Co. | 1983 | — |
| −3 | K973268 | Microaire Power Aspiration Device Pad System | Microaire Surgical Instruments, Inc. | 1997 | 1 |
| −2 | K984363 | XPS Tissue Aspiration System, XPS Straightshot or Model 2000 Microdebrider… | Xomed, Inc. | 1999 | — |
| −1 | K040239 | Supraflow Console | Neomedix Corp. | 2004 | 1 |
| 0 (this device) | K080845 | Orwell Fluid Collection and Disposal System | Cardinalhealth | 2008 | — |
| +1 | K090759 | Biodrain Streamway Fluid Management System | Biodrain Medical, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1998 | 2 | 0 |
| 2001 | 1 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 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.
1 device in this family has a Class I recall. 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 JCX device
- #1 K250964 Protable Phlegm Suction Unit (JMA D01)score 12.2 · 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? (2)
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 |
|---|---|---|---|
| * | K012991 | Neptune Waste Management StstemSummary page 1…Disposal System Classification: Class IIper 21 CFR § 878.4780 Classification Name: Powered Suction Pump Predicate Device: K012991 - Stryker Neptune Waste Management System and K040239 - Neomedix Corp. Supraflow Console Descri… | 2001 |
| * | K040239 | Supraflow ConsoleSummary page 1…ication Name: Powered Suction Pump Predicate Device: K012991 - Stryker Neptune Waste Management System and K040239 - Neomedix Corp. Supraflow Console Description: The Disposal Station is a stationary unit located in a utility area. The ORwellTM… | 2004 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090759 | Biodrain Streamway Fluid Management System | 2009 | 0 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K012991Neptune Waste Management StstemStryker Instruments · 2001 · Direct predicate · ◆ in the 2001 ancestors bar of FIG. 14 Class I recalls
What does this lineage say?
- The line of descent spans 25 years and passes through 5 companies; a new generation was cleared every 5.0 years on median.
- 3 of the 8 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K090759 (Biodrain Medical, Inc., 2009) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K012991.
How does its category compare?
All JCX devicesJCX Apparatus, Suction, Ward Use, Portable, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · JCX
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JCX
30in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JCX
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JCX
45in 2025
MAUDE reports naming product code JCX, 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 | — | 0 | 48 |
| 2008 | 4 | 43 | 3 | 57 |
| 2009 | 1 | — | 0 | 34 |
| 2010 | 1 | — | 0 | 7 |
| 2011 | 2 | — | 2 | 9 |
| 2012 | 2 | — | 0 | 18 |
| 2013 | 5 | 144 | 2 | 12 |
| 2014 | 4 | 106 | 0 | 68 |
| 2015 | 0 | — | 0 | 118 |
| 2016 | 2 | — | 0 | 119 |
| 2017 | 2 | — | 1 | 102 |
| 2018 | 2 | — | 0 | 170 |
| 2019 | 3 | 30 | 0 | 132 |
| 2020 | 0 | — | 1 | 89 |
| 2021 | 0 | — | 0 | 227 |
| 2022 | 1 | — | 0 | 215 |
| 2023 | 1 | — | 0 | 187 |
| 2024 | 1 | — | 0 | 103 |
| 2025 | 2 | — | 0 | 45 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
The ORwell TM Fluid Collection and Disposal System is intended to be used in the Operating Rooms, Surgical Centers, and Doctors' Offices to collect and dispose of fluid waste.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080845 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080845: Orwell Fluid Collection and Disposal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080845
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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