510(k) · Cleared
ClearedTrinity Sleeve (S)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Delphi Consulting Group · JOW Sleeve, Limb, Compressible
Cleared on Feb 22, 1996 after a 148-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.
- Decided
- Feb 22, 1996
- Review
- 148 days
- Class
- Class II
- Product code
- JOW
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 3 citing it directly.
- This deviceK954489 Trinity Sleeve (S)Delphi Consulting Group · 1996
- Descendant · cites it directly · 0 of its ownK983680 Trinity II Single Chamber DVT PumpDelphi Consulting Group · 1999
- Descendant · cites it directly · 0 of its ownK963957 Trinity DVT SystemDelphi Consulting Group · 1997
- Descendant · cites it directly · 0 of its ownK970014 Trinity Sleeves, Huntleigh Pump Compatible (T.B.D.)Delphi Consulting Group · 1997
Most influential descendants
Showing 3 of 3 · See all- K983680Trinity II Single Chamber DVT PumpDelphi Consulting Group · 1999 · cites it directly0descendants
- K963957Trinity DVT SystemDelphi Consulting Group · 1997 · cites it directly0descendants
- K970014Trinity Sleeves, Huntleigh Pump Compatible (T.B.D.)Delphi Consulting Group · 1997 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K954489 | Trinity Sleeve (S) | Delphi Consulting Group | 1996 | — |
| +1 | K983680 | Trinity II Single Chamber DVT Pump | Delphi Consulting Group | 1999 | — |
| +1 | K963957 | Trinity DVT System | Delphi Consulting Group | 1997 | — |
| +1 | K970014 | Trinity Sleeves, Huntleigh Pump Compatible (T.B.D.) | Delphi Consulting Group | 1997 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 2 | 0 |
| 1999 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JOW? 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 JOW device
- #1 K253555 Flexitouch® Plus Advanced Pneumatic…score 14.8 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K983680 (Delphi Consulting Group, 1999) has gone furthest, with 0 descendants of its own.
How does its category compare?
All JOW devicesJOW Sleeve, Limb, Compressible: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JOW
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JOW
168in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JOW
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JOW
24in 2025
MAUDE reports naming product code JOW, 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 | 6 | 66 | 0 | 12 |
| 2008 | 4 | 112 | 7 | 36 |
| 2009 | 3 | 84 | 0 | 45 |
| 2010 | 18 | 71 | 2 | 66 |
| 2011 | 11 | 104 | 3 | 50 |
| 2012 | 13 | 63 | 2 | 100 |
| 2013 | 17 | 94 | 0 | 169 |
| 2014 | 16 | 91 | 0 | 93 |
| 2015 | 10 | 160 | 0 | 137 |
| 2016 | 9 | 121 | 0 | 150 |
| 2017 | 9 | 116 | 1 | 149 |
| 2018 | 11 | 136 | 0 | 114 |
| 2019 | 11 | 88 | 1 | 102 |
| 2020 | 14 | 158 | 0 | 50 |
| 2021 | 16 | 132 | 0 | 34 |
| 2022 | 7 | 80 | 0 | 27 |
| 2023 | 6 | 160 | 0 | 57 |
| 2024 | 8 | 197 | 0 | 30 |
| 2025 | 7 | 168 | 0 | 24 |
| 2026 | 6 | 252 | 0 | — |
https://510kreport.com/device/K954489 · printed Nov 4, 2026
Cite this page
510(k) Report. “K954489: Trinity Sleeve (S).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K954489
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026