510(k) Report

510(k) · Cleared

Cleared

Pulstar Logix Intermittent Pneumatic Compression System

K123308510(k) TraditionalCleared Feb 8, 2013107-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

Albahealth, LLC · JOW Sleeve, Limb, Compressible

Cleared on Feb 8, 2013 as substantially equivalent to K770956 (Hamilton Industries, Inc., 1977) and 1 other predicate after a 107-day review. Its family tree reaches back 1 generation to 1977.

Decided
Feb 8, 2013
Review
107 days
Class
Class II
Product code
JOW
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K770956 (1977). 2 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1996: 1 other ancestorK770956 · Pas Anti-Embolism System · Hamilton Industries, Inc. · 19771980199020002010
Other ancestors, by generation 1 generation back: 1 other ancestor K770956 · Pas Anti-Embolism System · Hamilton Industries, Inc. · 19770
  1. Root · 1 generation backK770956 Pas Anti-Embolism SystemHamilton Industries, Inc. · 1977
  2. This deviceK123308 Pulstar Logix Intermittent Pneumatic Compression SystemAlbahealth, LLC · 2013
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K770956Pas Anti-Embolism SystemHamilton Industries, Inc.1977—
0 (this device)K123308Pulstar Logix Intermittent Pneumatic Compression SystemAlbahealth, LLC2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199610
FIG. 1 — Lineage of K123308, 1977–2013Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K253555 Flexitouch® Plus Advanced Pneumatic…score 14.8 · 11 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K770956Pas Anti-Embolism System
Summary page 3
…sufficiency Note: The indications for use of the Puistar Logix Pneumatic Compression systems are the same as predicate K770956B and K961405 PAGE…
Hamilton Industries, Inc.1977—
*K961405Alba Health Pas Wrap System
Summary page 3
…Note: The indications for use of the Puistar Logix Pneumatic Compression systems are the same as predicate K770956B and K961405 PAGE PLEASE DO NOT WRITE BlELOW TIS LINE -…
Alba-Waldensian, Inc.19961

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?

  • 1 of the 2 ancestors has a recall of any class.

How does its category compare?

All JOW devices

JOW Sleeve, Limb, Compressible: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

FDA decisions per year · JOW

7in 2025

2007: 62008: 42009: 32010: 182011: 112012: 132013: 172014: 162015: 102016: 92017: 92018: 112019: 112020: 142021: 162022: 72023: 62024: 82025: 72026 (partial year): 6
2007high 18 (2010) · low 3 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JOW

168in 2025

2007: 66 days median2008: 112 days median2009: 84 days median2010: 71 days median2011: 104 days median2012: 63 days median2013: 94 days median2014: 91 days median2015: 160 days median2016: 121 days median2017: 116 days median2018: 136 days median2019: 88 days median2020: 158 days median2021: 132 days median2022: 80 days median2023: 160 days median2024: 197 days median2025: 168 days median2026 (partial year): 252 days median
2007high 252 (2026) · low 63 (2012)2026

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

Recalls per year · JOW

1in 2019

2008: 72010: 22011: 32012: 22017: 12019: 1
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

2007: 122008: 362009: 452010: 662011: 502012: 1002013: 1692014: 932015: 1372016: 1502017: 1492018: 1142019: 1022020: 502021: 342022: 272023: 572024: 302025: 24
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007666012
20084112736
2009384045
20101871266
201111104350
201213632100
201317940169
20141691093
2015101600137
201691210150
201791161149
2018111360114
201911881102
202014158050
202116132034
2022780027
20236160057
20248197030
20257168024
202662520—

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 urogemtal surgery

Neurosurgery, subarachnoid hemorrhage and stroke

Bedridden Medical patients

b. Patients with chronic venous insufficiency

Note: The indications for use of the Puistar Logix Pneumatic Compression systems are the same as predicate K770956B and K961405

Indications for use as stated in the FDA 510(k) statement.

More from Albahealth, LLC

2 FDA decisions under this applicant name. See the company

  • K141609Pulstar Logix PumpAlbahealth, LLC · 2014

Recent decisions in JOW

The JOW category page

  • K261807Sequential Circulator (SC-4004-DL, SC-4008-DL)Bio Compression Systems, Inc. · 2026
  • K254217AerloomEvolym, LLC · 2026
  • K253555Flexitouch® Plus Advanced Pneumatic Compression SystemTactile Medical · 2026
  • K253386DVT GarmentVistar Medical Supplies Co., Ltd. · 2026
  • K250242Compression Therapy Device (LGT-2202DVT)Guangzhou Longest Medical Technology Co., Ltd. · 2026

https://510kreport.com/device/K123308 · printed Nov 6, 2026

Cite this page

510(k) Report. “K123308: Pulstar Logix Intermittent Pneumatic Compression System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123308

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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