510(k) · Cleared

Cleared

Cirona 6400

K161209510(k) SpecialCleared May 31, 201633-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

Devon Medical Products · JOW Sleeve, Limb, Compressible

Cleared on May 31, 2016 after a 33-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 later devices descend from it.

Decided: May 31, 2016
Review: 33 days
Class: Class II
Product code: JOW
Recalls: None
Predicates: 0

2 later devices descend from it, 1 citing it directly.

This deviceK161209 Cirona 6400Devon Medical Products · 2016
Descendant · cites it directly · 1 of its ownK200285 VenaOneVena Group, LLC · 2020
Descendant · 2 generations on · 0 of its ownK212731 Circul8 ProOrtho8, Inc. · 2021

Most influential descendants

Showing 2 of 2 · See all

K200285VenaOneVena Group, LLC · 2020 · cites it directly1descendant
K212731Circul8 ProOrtho8, Inc. · 2021 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K161209	Cirona 6400	Devon Medical Products	2016	—
+1	K200285	VenaOne	Vena Group, LLC	2020	—
+2	K212731	Circul8 Pro	Ortho8, Inc.	2021	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2020	1	0
2021	1	0

FIG. 1 — Lineage of K161209, 2016–2021Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K200285	VenaOne	Vena Group, LLC	2020	1

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, K200285 (Vena Group, LLC, 2020) has gone furthest, with 1 descendant of its own.

How does its category compare?

All JOW devices

JOW Sleeve, Limb, Compressible: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 Cirona 6400 disposable deep vein thrombosis prevention system is intended to be an easy to use portable system, prescribed by a physician, to help prevent the onset of DVT in patients by stimulating blood flow in the extremities (simulating muscle contractions). This device can be used in the home or clinical settings to: * Aid in the prevention of DVT » Enhance blood circulation * Diminish post-operative pain and swelling » Reduce wound healing time…

Read the full statement (120 words)

This device can be used in the home or clinical settings to:

* Aid in the prevention of DVT

» Enhance blood circulation

* Diminish post-operative pain and swelling

» Reduce wound healing time

* Aid in the treatment of: stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers, chronic venous insufficiency and reduction of edema in the lower limbs

* As a prophylaxis for DVT by persons expecting to be stationary for long periods of time

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K161209 · printed Nov 4, 2026

Cite this page

510(k) Report. “K161209: Cirona 6400.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K161209

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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