510(k) · Cleared
ClearedDornoch Duo Suction Cart with: DL2800 Lid, CL500 Lid, Dornoch Quad Suction Cart with: DL2800 Lid, CL500 Lid
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 Mar 21, 2014 after a 99-day review. The FDA summary names its predicate without a number. 2 later devices descend from it.
- Decided
- Mar 21, 2014
- Review
- 99 days
- Class
- Class II
- Product code
- JCX
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
- This deviceK133786 Dornoch Duo Suction Cart with: DL2800 Lid, CL500 Lid, Dornoch Quad…Dornoch Medical Systems, Inc. · 2014
- Descendant · cites it directly · 1 of its ownK162421 IntelliCartTM SystemDornoch Medical Systems · 2016
- Descendant · 2 generations on · 0 of its ownK172481 IntelliCart SystemDornoch Medical Systems · 2017
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K133786 | Dornoch Duo Suction Cart with: DL2800 Lid, CL500 Lid, Dornoch Quad Suction… | Dornoch Medical Systems, Inc. | 2014 | — |
| +1 | K162421 | IntelliCartTM System | Dornoch Medical Systems | 2016 | — |
| +2 | K172481 | IntelliCart System | Dornoch Medical Systems | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 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 JCX? 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? (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 |
|---|---|---|---|
| * | — | Dornoch Ultra Suction System Named without a submission number |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K162421 | IntelliCartTM System | 2016 | 1 |
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?
- Of its descendants, K162421 (Dornoch Medical Systems, 2016) has gone furthest, with 1 descendant 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. 2014, 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/K133786 · printed Nov 4, 2026
Cite this page
510(k) Report. “K133786: Dornoch Duo Suction Cart with: DL2800 Lid, CL500 Lid, Dornoch Quad Suction Cart with: DL2800 Lid, CL500 Lid.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K133786
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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