510(k) · Cleared

Cleared

PulseFlowDF

K150806510(k) TraditionalCleared Dec 16, 2015265-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

Pulseflow Technologies · JOW Sleeve, Limb, Compressible

Cleared on Dec 16, 2015 as substantially equivalent to K981311 (Kci New Technologies, Inc., 1999) after a 265-day review. Its family tree reaches back 2 generations to 1995.

Decided: Dec 16, 2015
Review: 265 days
Class: Class II
Product code: JOW
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K944567 (1995). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK944567 Cowboy XKinetic Concepts, Inc. · 1995 · Recalled
1 generation backK981311 Cowboy XVKci New Technologies, Inc. · 1999
This deviceK150806 PulseFlowDFPulseflow Technologies · 2015

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K944567	Cowboy X	Kinetic Concepts, Inc.	1995	1
−1	K981311	Cowboy XV	Kci New Technologies, Inc.	1999	—
0 (this device)	K150806	PulseFlowDF	Pulseflow Technologies	2015	—

FIG. 1 — Lineage of K150806, 1995–2015Source: 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

Get a 510(k) Report

What was it cleared against? (1)

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
*	K981311	Cowboy XV Summary page 4 …ssible limb sleeve Product Code: JOW Classification Panel: Cardiovascular Predicate Cowboy XV, marketed as PlexiPulse, K981311 Device Device PulseFlowDF is an off-loading boot with a built in air bladder in the insole for Description intermi…	Kci New Technologies, Inc.	1999	—

Also cleared against K981311: 7 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?

The line of descent spans 20 years and passes through 3 companies; a new generation was cleared every 16.6 years on median.
1 of the 2 ancestors has a recall of any class.
7 other devices also cite its predicate K981311.

How does its category compare?

All JOW devices

JOW Sleeve, Limb, Compressible: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.

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?

The PulseFlowDF™ is designed to enhance blood circulation in the venules and arterioles in patients with diabetic foot ulcers of the lower extremities. PulseFlowDF is intended for patients in the home who would benefit from increased blood flow to: • Treat and assist healing of cutaneous ulceration (wounds) • Reduce wound healing time • Enhance arterial circulation (blood flow) • Prevent venous stasis (slowing of blood flow) • Reduce compartmental…

Read the full statement (106 words)

The PulseFlowDF™ is designed to enhance blood circulation in the venules and arterioles in patients with diabetic foot ulcers of the lower extremities.

PulseFlowDF is intended for patients in the home who would benefit from increased blood flow to:

• Treat and assist healing of cutaneous ulceration (wounds)

• Reduce wound healing time

• Enhance arterial circulation (blood flow)

• Prevent venous stasis (slowing of blood flow)

• Reduce compartmental pressures

• Reduce edema (swelling)

• Reduce post-operative pain and swelling

• Reduce the need for anticoagulant medications (medications that thin the blood) and

• Prevent Deep Venous Thrombosis (DVT) (blood clots in the deep veins).

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K150806 · printed Nov 6, 2026

Cite this page

510(k) Report. “K150806: PulseFlowDF.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150806

Report an extraction error

Are you the manufacturer?

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