510(k) · Cleared

Cleared

Albahealth C.a.L.M. Sleeve, Model 59001

K020592510(k) TraditionalCleared Apr 3, 200240-day reviewClass II21 CFR 880.5780

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

Alba-Waldensian, Inc. · DWL Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)

Cleared on Apr 3, 2002 as substantially equivalent to K991570 (Beiersdorf-Jobt, Inc., 1999) after a 40-day review. Its family tree reaches back 1 generation to 1999.

Decided: Apr 3, 2002
Review: 40 days
Class: Class II
Product code: DWL
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K991570 (1999). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK991570 Jobst Ready-to-Wear Arm SleevesBeiersdorf-Jobt, Inc. · 1999
This deviceK020592 Albahealth C.a.L.M. Sleeve, Model 59001Alba-Waldensian, Inc. · 2002

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K991570	Jobst Ready-to-Wear Arm Sleeves	Beiersdorf-Jobt, Inc.	1999	—
0 (this device)	K020592	Albahealth C.a.L.M. Sleeve, Model 59001	Alba-Waldensian, Inc.	2002	—

FIG. 1 — Lineage of K020592, 1999–2002Source: 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 DWL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin 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
*	K991570	Jobst Ready-to-Wear Arm Sleeves Summary page 1 …he wrist area, with gradually decreasing compression through the upper arm. This is the same level of compression claimed for the Jobst Ready-to-Wear Arm Sleeve (510(k) #K991570) and the Juzo Expert Line Compression Arm Sleeve (510(k) # unknown). This gradient compression helps keep fluid from accumulating…	Beiersdorf-Jobt, Inc.	1999	—
*	—	Juzo Expert Line Compression Arm Sleeve Named without a submission number			—

Also cleared against K991570: 3 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?

Its one ancestor has no recall.
3 other devices also cite its predicate K991570.

How does its category compare?

All DWL devices

DWL Stocking, Medical Support (To Prevent Pooling Of Blood In Legs): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DWL

1in 2014

2007high 5 (2012) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DWL

111in 2013

2007high 214 (2010) · low 43 (2012)2026

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

Recalls per year · DWL

No recall names DWL since 2007.

Adverse event reports per year · DWL

2in 2025

2007high 10 (2012) · low 0 (2008)2025

MAUDE reports naming product code DWL, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	1	—	1
2008	0	—	0
2009	2	—	3
2010	3	214	7
2011	2	—	4
2012	5	43	10
2013	3	111	4
2014	1	—	2
2015	0	—	1
2016	0	—	0
2017	0	—	4
2018	0	—	2
2019	0	—	1
2020	0	—	3
2021	0	—	2
2022	0	—	1
2023	0	—	2
2024	0	—	0
2025	0	—	2
2026	0	—	—

What is it indicated for?

To assist in limb size maintenance of patients with mild to moderate edema or lymphedema of the arm,

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/K020592 · printed Nov 6, 2026

Cite this page

510(k) Report. “K020592: Albahealth C.a.L.M. Sleeve, Model 59001.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020592

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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