510(k) · Cleared
ClearedTransposal Ultra Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dornoch Medical Systems, Inc. · JCX Apparatus, Suction, Ward Use, Portable, Ac-Powered
Cleared on Apr 29, 2008 as substantially equivalent to K941527 (Product & Educational Services, 1994) and 2 other predicates after a 15-day review. Its family tree reaches back 2 generations to 1988. 1 of the 9 devices in its family, counting itself, has a Class I recall. 4 later devices descend from it.
- Decided
- Apr 29, 2008
- Review
- 15 days
- Class
- Class II
- Product code
- JCX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K874512 (1988). 4 ancestors in all. 4 later devices descend from it, 1 citing it directly. 1 of the 9 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK874512 Modified Biovac:Lfa Laser Fume Evacuation SystemStackhouse Assoc. · 1988
- 1 generation backK990037 Neptune Waste Management SystemAmerican Immuno Tech · 1999 · Recalled
- This deviceK081047 Transposal Ultra SystemsDornoch Medical Systems, Inc. · 2008
- Descendant · cites it directly · 3 of its ownK132671 Stryker Neptune 2 Waste Managment SystemStryker Corporation · 2013 · Recalled
- Descendant · 2 generations on · 1 of its ownK153407 Stryker Neptune 3 Waste Management SystemStryker Corporation · 2016 · Recalled
- Descendant · 2 generations on · 0 of its ownK222552 120V Neptune S Rover (0711-001-000);V2 4-Port Manifold…Stryker Instruments · 2022
- Descendant · 2 generations on · 0 of its ownK161358 Medline ReNewal Reprocessed Stryker Neptune 2 ManifoldsSurgical Instrument Service and Savings, Inc. · 2017
Class I recalls in this family
- K012991 Neptune Waste Management Ststemdirect predicate · 2001
Most influential descendants
Showing 4 of 4 · See all- K132671Stryker Neptune 2 Waste Managment SystemStryker Corporation · 2013 · cites it directly3descendants
- K153407Stryker Neptune 3 Waste Management SystemStryker Corporation · 2016 · 2 generations on1descendant
- K222552120V Neptune S Rover (0711-001-000);V2 4-Port Manifold (0750-400-000);V2 Specimen…Stryker Instruments · 2022 · 2 generations on0descendants
- K161358Medline ReNewal Reprocessed Stryker Neptune 2 ManifoldsSurgical Instrument Service and Savings, Inc. · 2017 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K874512 | Modified Biovac:Lfa Laser Fume Evacuation System | Stackhouse Assoc. | 1988 | — |
| −1 | K990037 | Neptune Waste Management System | American Immuno Tech | 1999 | 2 |
| 0 (this device) | K081047 | Transposal Ultra Systems | Dornoch Medical Systems, Inc. | 2008 | — |
| +1 | K132671 | Stryker Neptune 2 Waste Managment System | Stryker Corporation | 2013 | 5 |
| +2 | K153407 | Stryker Neptune 3 Waste Management System | Stryker Corporation | 2016 | 1 |
| +2 | K222552 | 120V Neptune S Rover (0711-001-000);V2 4-Port Manifold (0750-400-000);V2… | Stryker Instruments | 2022 | — |
| +2 | K161358 | Medline ReNewal Reprocessed Stryker Neptune 2 Manifolds | Surgical Instrument Service and Savings, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2001 | 1 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2022 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K941527 | Model 2300 General Purpose Suction PumpSummary page 1…exempt (GCX) o Product & Educational Services - Model 2300 general purpose suction pump - K941527 (JCX) o American Immuno Tech (Stryker) Neptune Waste Management System Rover -… | 1994 |
| * | K990037 | Neptune Waste Management SystemSummary page 1…K941527 (JCX) o American Immuno Tech (Stryker) Neptune Waste Management System Rover - K990037 (FYD) O Stryker- Neptune Waste Management Systems - K012991 (FYD)… | 1999 |
| * | K012991 | Neptune Waste Management StstemSummary page 1…ste Management System Rover - K990037 (FYD) O Stryker- Neptune Waste Management Systems - K012991 (FYD) Page 5.15 of 261 === Page 2… | 2001 |
| * | — | Steris - SafeCycle 40 Named without a submission number |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K132671 | Stryker Neptune 2 Waste Managment System | 2013 | 3 |
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 20 years and passes through 3 companies; a new generation was cleared every 11.6 years on median.
- 2 of the 4 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K132671 (Stryker Corporation, 2013) has gone furthest, with 3 descendants of its own.
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 Dornoch Transposal Ultra System is self-powered suction / vacuum pump intended to
collect and dispose of liquid waste within Hospital Operating Rooms, Pathology Labs,
Surgical Outpatient Centers, and Doctor's Offices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081047 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081047: Transposal Ultra Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081047
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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