510(k) · Cleared

Cleared

Uuhc Reprocessed Compression Sleeve Devices

K031189510(k) TraditionalCleared Oct 16, 2003184-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

University of Utah Hospitals and Clinics · JOW Sleeve, Limb, Compressible

Cleared on Oct 16, 2003 as substantially equivalent to K890938 (Kendall Healthcare Products Co. Div.Of Tyco Health, 1989) after a 184-day review. Its family tree reaches back 1 generation to 1989. 2 later devices descend from it.

Decided: Oct 16, 2003
Review: 184 days
Class: Class II
Product code: JOW
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K890938 (1989). 2 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK890938 Kendall SCD Therapeutic SystemKendall Healthcare Products Co. Div.Of Tyco Health · 1989
This deviceK031189 Uuhc Reprocessed Compression Sleeve DevicesUniversity of Utah Hospitals and Clinics · 2003
Descendant · cites it directly · 0 of its ownK121145 Renu Medical Reprocessed Aircast Venaflow Calf Garments/All Sizes…Renu Medical, Inc. · 2012
Descendant · cites it directly · 0 of its ownK080551 University Health Care Processed Alternating Leg Pressure (Uhc Apl)…University of Utah Hospitals and Clinics · 2008

Most influential descendants

Showing 2 of 2 · See all

K121145Renu Medical Reprocessed Aircast Venaflow Calf Garments/All Sizes, Renu Medical…Renu Medical, Inc. · 2012 · cites it directly0descendants
K080551University Health Care Processed Alternating Leg Pressure (Uhc Apl) Sleeve DeviceUniversity of Utah Hospitals and Clinics · 2008 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K890938	Kendall SCD Therapeutic System	Kendall Healthcare Products Co. Div.Of Tyco Health	1989	—
0 (this device)	K031189	Uuhc Reprocessed Compression Sleeve Devices	University of Utah Hospitals and Clinics	2003	—
+1	K121145	Renu Medical Reprocessed Aircast Venaflow Calf Garments/All Sizes, Renu…	Renu Medical, Inc.	2012	—
+1	K080551	University Health Care Processed Alternating Leg Pressure (Uhc Apl) Sleeve…	University of Utah Hospitals and Clinics	2008	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0
2012	1	0

FIG. 1 — Lineage of K031189, 1989–2012Source: 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

Type	Number	Device	Applicant	Decided	Recalls
*	K890938	Kendall SCD Therapeutic System Summary page 1 …ass 800 Panel Product Code JOW Predicate Device: The UUHC’S Reprocessed CSD is substantially equivalent to the legally marketed Kendall K94664 and K89093 8 Compression Sleeve Predicate Devices. Device Description: The description of UUHC’s Reprocessed Compression Sleeves is substanti…	Kendall Healthcare Products Co. Div.Of Tyco Health	1989	—
Kept off the family tree	K094664	Kendall model 6325 Compression Sleeve Device Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

Also cleared against K890938: 4 other devices →

What descends from it? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K121145	Renu Medical Reprocessed Aircast Venaflow Calf Garments/All Sizes, Renu Medical…	Renu Medical, Inc.	2012	0
K080551	University Health Care Processed Alternating Leg Pressure (Uhc Apl) Sleeve Device	University of Utah Hospitals and Clinics	2008	0

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?

Its one ancestor has no recall.
Of its descendants, K121145 (Renu Medical, Inc., 2012) has gone furthest, with 0 descendants of its own.
4 other devices also cite its predicate K890938.

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?

University of Utah Hospital and Clinics (UrnrC) reprocessing methods do not change the intended use of the compression sleeve devices (CSDs) from the intended use of, Kendall’s K890938 model 5325 and K94 64 model 6325 predicate devices. Both UUHC’s reprocessed device and Kendall’s predicate CSDs are intended to be placed on the intact skin of the patient’s limb and to be periodically inflated for preventing pooling of blood in the patient’s limb.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K031189 · printed Nov 5, 2026

Cite this page

510(k) Report. “K031189: Uuhc Reprocessed Compression Sleeve Devices.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K031189

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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