510(k) · Cleared
ClearedPulstar Logix Pump
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Albahealth, LLC · JOW Sleeve, Limb, Compressible
Cleared on Jul 15, 2014 after a 29-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it.
- Decided
- Jul 15, 2014
- Review
- 29 days
- Class
- Class II
- Product code
- JOW
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK141609 Pulstar Logix PumpAlbahealth, LLC · 2014
- Descendant · cites it directly · 2 of its ownK142728 ActiveCare+SFT; ActiveCare+SFT HomeCare…Medical Compressions System (Dbn), Ltd. · 2014
- Descendant · 2 generations on · 1 of its ownK151377 ActiveCare+SFT;ActiveCare+SFT HomeCare…Medical Compression System (Dbn), Ltd. · 2015
- Descendant · 3 generations on · 0 of its ownK160431 ActiveCare HomeMedical Compression Systems (Dbn), Ltd. · 2016
Most influential descendants
Showing 3 of 3 · See all- K142728ActiveCare+SFT; ActiveCare+SFT HomeCare (ActiveCare+SFT-sub-category), ActiveCare+DTx…Medical Compressions System (Dbn), Ltd. · 2014 · cites it directly2descendants
- K151377ActiveCare+SFT;ActiveCare+SFT HomeCare, ActiveCare+DTx;ActiveCare+DTx HomeCareMedical Compression System (Dbn), Ltd. · 2015 · 2 generations on1descendant
- K160431ActiveCare HomeMedical Compression Systems (Dbn), Ltd. · 2016 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K141609 | Pulstar Logix Pump | Albahealth, LLC | 2014 | — |
| +1 | K142728 | ActiveCare+SFT; ActiveCare+SFT HomeCare (ActiveCare+SFT-sub-category)… | Medical Compressions System (Dbn), Ltd. | 2014 | — |
| +2 | K151377 | ActiveCare+SFT;ActiveCare+SFT HomeCare, ActiveCare+DTx;ActiveCare+DTx HomeCare | Medical Compression System (Dbn), Ltd. | 2015 | — |
| +3 | K160431 | ActiveCare Home | Medical Compression Systems (Dbn), Ltd. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K142728 | ActiveCare+SFT; ActiveCare+SFT HomeCare (ActiveCare+SFT-sub-category), ActiveCare+DTx… | 2014 | 2 |
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?
- Of its descendants, K142728 (Medical Compressions System (Dbn), Ltd., 2014) has gone furthest, with 2 descendants 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. 2014, this device’s year, is highlighted.
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?
Patients at Risk for DVT:
These include:
a. Major orthopedic procedures e.g. knee surgery
Major abdominal thoracic surgery including urogenital surgery
Neurosurgery, subarachnoid hemorrhage and stroke
Bedridden Medical patients
b. Patients with chronic venous insufficiency
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K141609 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141609: Pulstar Logix Pump.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141609
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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