510(k) · Cleared

Cleared

Linear Pump #4370975

K830577510(k) TraditionalCleared May 25, 198391-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

Wright Linear Pump, Inc. · JOW Sleeve, Limb, Compressible

Cleared on May 25, 1983 after a 91-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 60 later devices descend from it.

Decided: May 25, 1983
Review: 91 days
Class: Class II
Product code: JOW
Recalls: None
Predicates: 0

60 later devices descend from it, 3 citing it directly.

This deviceK830577 Linear Pump #4370975Wright Linear Pump, Inc. · 1983
Descendant · cites it directly · 55 of its ownK013436 Normatec PCDNormatec, Inc. · 2001
Descendant · 2 generations on · 52 of its ownK112890 Normatec MVPNormaTec Industries, LP · 2012
Descendant · 3 generations on · 51 of its ownK160608 NormaTec Pulse and NormaTec Pulse ProNormaTec Industries, LP · 2016
Descendant · 4 generations on · 38 of its ownK182668 Rapid Reboot Compression Therapy SystemRapid Reboot Recovery Products, LLC · 2018
Descendant · 4 generations on · 20 of its ownK193354 Air Compression Therapy DeviceShenzhen Dongjilian Electronics Co., Ltd. · 2020

Showing 5 of 60 descendants. See all descendants

Descendants cleared per year

1996high 12 (2021) · low 0 (1997)2026

Most influential descendants

Showing 5 of 60 · See all

K013436Normatec PCDNormatec, Inc. · 2001 · cites it directly55descendants
K112890Normatec MVPNormaTec Industries, LP · 2012 · 2 generations on52descendants
K160608NormaTec Pulse and NormaTec Pulse ProNormaTec Industries, LP · 2016 · 3 generations on51descendants
K182668Rapid Reboot Compression Therapy SystemRapid Reboot Recovery Products, LLC · 2018 · 4 generations on38descendants
K193354Air Compression Therapy DeviceShenzhen Dongjilian Electronics Co., Ltd. · 2020 · 4 generations on20descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K830577	Linear Pump #4370975	Wright Linear Pump, Inc.	1983	—
+1	K013436	Normatec PCD	Normatec, Inc.	2001	—
+2	K112890	Normatec MVP	NormaTec Industries, LP	2012	—
+3	K160608	NormaTec Pulse and NormaTec Pulse Pro	NormaTec Industries, LP	2016	—
+4	K182668	Rapid Reboot Compression Therapy System	Rapid Reboot Recovery Products, LLC	2018	—
+4	K193354	Air Compression Therapy Device	Shenzhen Dongjilian Electronics Co., Ltd.	2020	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1996	2	0
2001	1	0
2007	1	0
2012	1	0
2013	1	0
2016	2	0
2018	3	0
2019	2	0
2020	4	0
2021	12	0
2022	11	0
2023	3	0
2024	6	0
2025	6	0
2026	5	0

FIG. 1 — Lineage of K830577, 1983–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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 has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (60)

See all 60

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K013436	Normatec PCD	Normatec, Inc.	2001	55
K961797	WLP Gradient Sequential Version/WLP Prolite/WLP WLP-II Lite	Wright Linear Pump, Inc.	1996	2
K961292	WLP Sequential Version Model WLP Solo VI, WLP Solo Sequential	Wright Linear Pump, Inc.	1996	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, K013436 (Normatec, Inc., 2001) has gone furthest, with 55 descendants 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.

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	—

https://510kreport.com/device/K830577 · printed Nov 6, 2026

Cite this page

510(k) Report. “K830577: Linear Pump #4370975.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K830577

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026