510(k) · Cleared
ClearedTrinity Sleeves, Huntleigh Pump Compatible (T.B.D.)
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 Aug 6, 1997 as substantially equivalent to K954489 (Delphi Consulting Group, 1996) and 1 other predicate after a 216-day review. Its family tree reaches back 1 generation to 1991.
- Decided
- Aug 6, 1997
- Review
- 216 days
- Class
- Class II
- Product code
- JOW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K910188 (1991). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK910188 Flowplus AC330 Pump GarmentsHuntleigh Technology, Inc. · 1991
- This deviceK970014 Trinity Sleeves, Huntleigh Pump Compatible (T.B.D.)Delphi Consulting Group · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K910188 | Flowplus AC330 Pump Garments | Huntleigh Technology, Inc. | 1991 | — |
| 0 (this device) | K970014 | Trinity Sleeves, Huntleigh Pump Compatible (T.B.D.) | Delphi Consulting Group | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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? (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 |
|---|---|---|---|
| * | K954489 | Trinity Sleeve (S)Summary page 1…andards for the Compressible Limb Sleeve are in effect. PREDICATED DEVICE Trinity Huntleigh Pump Compatible Sleeves are the same as the sleeves released to market under K954489, 27-SEP-95, Trinity Sleeve(s), Delphi Consulting Group. INDICATIONS The Trinity Huntleigh Pump Compatible Sleeves is designed t… | 1996 |
| * | K910188 | Flowplus AC330 Pump GarmentsSummary page 2…ame as the sleeves released to market under K954489, 27-SEP-95, Trinity Sleeve(s), Delphi Consulting Group and sleeve tubing pump connector same as Huntleigh Technology, K910188, Pump Flowtron DVT Model ACS500DVT with pressure range of 20-60 mmHg. MATERIALS Cover is made from soft brushed nylon with hooks… | 1991 |
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?
- None of the 2 ancestors has a recall.
- 2 other devices also cite its predicate K954489.
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 | — |
What is it indicated for?
The Trinity Sleeve(s), Huntleigh Technology Pump Compatible is designed to reduce pooling of blood, increase venous blood flow in the lower extremities of the recumbent patient to reduce deep vein thrombosis and pulmonary embolism.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K970014 · printed Nov 4, 2026
Cite this page
510(k) Report. “K970014: Trinity Sleeves, Huntleigh Pump Compatible (T.B.D.).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970014
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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