510(k) · Cleared

Cleared

Trinity DVT System

K963957510(k) TraditionalCleared Nov 4, 1997398-day reviewClass II21 CFR 870.5800

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Delphi Consulting Group · JOW Sleeve, Limb, Compressible

Cleared on Nov 4, 1997 as substantially equivalent to K954489 (Delphi Consulting Group, 1996) and 1 other predicate after a 398-day review. Its family tree reaches back 1 generation to 1991.

Decided: Nov 4, 1997
Review: 398 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.

By dateBy generation

Root · 1 generation backK910188 Flowplus AC330 Pump GarmentsHuntleigh Technology, Inc. · 1991
This deviceK963957 Trinity DVT SystemDelphi 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)	K963957	Trinity DVT System	Delphi Consulting Group	1997	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0

FIG. 1 — Lineage of K963957, 1991–1997Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K954489	Trinity Sleeve (S) Summary page 1 …Compressible LLimb Sleeve, Class No Performance Standards for the Compressible Limb Sleeve are in effect. Sleeves are the same as the sleeves released to market under K954489, 27-SEP-95, Trinity Sleeve(s), Delphi Consulting Group. The pump is substantial equivalent to the Huntleigh Technology, K910188.…	Delphi Consulting Group	1996	—
*	K910188	Flowplus AC330 Pump Garments Summary page 1 …e as the sleeves released to market under K954489, 27-SEP-95, Trinity Sleeve(s), Delphi Consulting Group. The pump is substantial equivalent to the Huntleigh Technology, K910188. The Trinity DVT System(sleevk is designed to reduce pooling of blood, increase venous bicod flow in the lower extremities of th…	Huntleigh Technology, Inc.	1991	—

Also cleared against K954489: 2 other devices →

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 devices

JOW Sleeve, Limb, Compressible: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JOW

7in 2025

2007high 18 (2010) · low 3 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JOW

168in 2025

2007high 252 (2026) · low 63 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JOW

1in 2019

2007high 7 (2008) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JOW

24in 2025

2007high 169 (2013) · low 12 (2007)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 DVT System 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/K963957 · printed Nov 4, 2026

Cite this page

510(k) Report. “K963957: Trinity DVT System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K963957

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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