510(k) · Cleared

Cleared

PCD 737A

K140642510(k) TraditionalCleared Jun 10, 201490-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

Mego Afek AC, Ltd. · JOW Sleeve, Limb, Compressible

Cleared on Jun 10, 2014 after a 90-day review. The FDA summary names no predicate by number.

Decided: Jun 10, 2014
Review: 90 days
Class: Class II
Product code: JOW
Recalls: None
Predicates: 0

The FDA summary names no predicate by number.

FIG. 1 — Lineage of K140642Source: FDA 510(k) database · 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

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What was it cleared against?

The FDA summary names no predicate by number.

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.

How does its category compare?

All JOW devices

JOW 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

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?

PCD 737A is intended for use by medical professionals, and patients who are under medical supervision, in treating many conditions such as: * Primary lymphedema * Secondary lymphedema * Venous insufficiency * Venous stasis ulcers * Dysfunction of the muscle pump * Post mastectomy edema * Edema following trauma and sports issues * Post immobilization edema * Reducing wound healing time * Prevention of deep vein thrombosis (DVT) in patients who may be…

Read the full statement (116 words)

PCD 737A is intended for use by medical professionals, and patients who are under medical supervision, in treating many conditions such as:

* Primary lymphedema

* Secondary lymphedema

* Venous insufficiency

* Venous stasis ulcers

* Dysfunction of the muscle pump

* Post mastectomy edema

* Edema following trauma and sports issues

* Post immobilization edema

* Reducing wound healing time

* Prevention of deep vein thrombosis (DVT) in patients who may be susceptible

* Reduction of pain and swelling after injury and surgery

* Enhancement Of venous circulation

* Prevention of venous stasis

* Assistance in healing of cutaneous ulcers

* Reduction of compartmental pressures

The device is intended for hospital, home, and clinic use.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K140642 · printed Nov 6, 2026

Cite this page

510(k) Report. “K140642: PCD 737A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140642

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Page last updated Nov 3, 2026