510(k) · Cleared
Recalled · 2011Alba Health Pas Wrap System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alba-Waldensian, Inc. · JOW Sleeve, Limb, Compressible
Cleared on Dec 26, 1996 after a 259-day review. The FDA summary names its predicate without a number. 4 later devices descend from it. It has been recalled once.
- Decided
- Dec 26, 1996
- Review
- 259 days
- Class
- Class II
- Product code
- JOW
- Recalls
- 1
- Predicates
- 0
4 later devices descend from it, 3 citing it directly.
- This deviceK961405 Alba Health Pas Wrap SystemAlba-Waldensian, Inc. · 1996
- Descendant · cites it directly · 1 of its ownK024074 Reprocessed Compression SleevesAlliance Medical Corp. · 2003
- Descendant · cites it directly · 0 of its ownK123308 Pulstar Logix Intermittent Pneumatic Compression SystemAlbahealth, LLC · 2013
- Descendant · 2 generations on · 0 of its ownK100909 Reprocessed Compression SleevesAscent Healthcare Solutions · 2010 · Recalled
- Descendant · cites it directly · 0 of its ownK052691 Suretek Medical Reprocessed Compression SleevesSuretek Medical · 2006
Most influential descendants
Showing 4 of 4 · See all- K024074Reprocessed Compression SleevesAlliance Medical Corp. · 2003 · cites it directly1descendant
- K123308Pulstar Logix Intermittent Pneumatic Compression SystemAlbahealth, LLC · 2013 · cites it directly0descendants
- K100909Reprocessed Compression SleevesAscent Healthcare Solutions · 2010 · 2 generations on0descendants
- K052691Suretek Medical Reprocessed Compression SleevesSuretek Medical · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K961405 | Alba Health Pas Wrap System | Alba-Waldensian, Inc. | 1996 | — |
| +1 | K024074 | Reprocessed Compression Sleeves | Alliance Medical Corp. | 2003 | — |
| +1 | K123308 | Pulstar Logix Intermittent Pneumatic Compression System | Albahealth, LLC | 2013 | — |
| +2 | K100909 | Reprocessed Compression Sleeves | Ascent Healthcare Solutions | 2010 | 1 |
| +1 | K052691 | Suretek Medical Reprocessed Compression Sleeves | Suretek Medical | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 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 |
|---|---|---|---|
| * | — | Jobst Athrombic Pump System 2000 Named without a submission number | |
| * | — | PAS-Pulsatile Anti-Embolism System Named without a submission number |
What descends from it? (4)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 12, 2011 | Not classified | Z-0183-2012 | Component change control | The wrap portion of the device was tearing at the seam. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K024074 (Alliance Medical Corp., 2003) has gone furthest, with 1 descendant 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/K961405 · printed Nov 6, 2026
Cite this page
510(k) Report. “K961405: Alba Health Pas Wrap System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K961405
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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