510(k) Report

510(k) · Cleared

Cleared

Lympha Press

K810338510(k) TraditionalCleared Oct 20, 1981253-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 · JOW Sleeve, Limb, Compressible

Cleared on Oct 20, 1981 after a 253-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 86 later devices descend from it.

Decided
Oct 20, 1981
Review
253 days
Class
Class II
Product code
JOW
Recalls
None
Predicates
0

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

Descendants, by year cleared 2001: 2 descendants cleared2004: 1 descendant cleared2012: 2 descendants cleared2011: 1 descendant cleared2008: 1 descendant cleared2010: 2 descendants cleared2016: 3 descendants cleared2007: 2 descendants cleared2020: 7 descendants cleared2013: 2 descendants cleared2017: 1 descendant cleared2015: 2 descendants cleared2025: 8 descendants cleared2018: 5 descendants cleared2023: 4 descendants cleared2021: 13 descendants cleared2019: 4 descendants cleared2024: 7 descendants cleared2026: 6 descendants cleared2022: 13 descendants cleared19801990200020102020
  1. This deviceK810338 Lympha PressMego Afek · 1981
  2. Descendant · cites it directly · 55 of its ownK013436 Normatec PCDNormatec, Inc. · 2001
  3. Descendant · 2 generations on · 52 of its ownK112890 Normatec MVPNormaTec Industries, LP · 2012
  4. Descendant · 3 generations on · 51 of its ownK160608 NormaTec Pulse and NormaTec Pulse ProNormaTec Industries, LP · 2016
  5. Descendant · 4 generations on · 38 of its ownK182668 Rapid Reboot Compression Therapy SystemRapid Reboot Recovery Products, LLC · 2018
  6. Descendant · cites it directly · 26 of its ownK013331 Lympha Press Plus DeviceMego Afek · 2001

Showing 5 of 86 descendants. See all descendants

Descendants cleared per year

2001: 22004: 12007: 22008: 12010: 22011: 12012: 22013: 22015: 22016: 32017: 12018: 52019: 42020: 72021: 132022: 132023: 42024: 72025: 82026: 6
2001high 13 (2021) · low 0 (2002)2026

Most influential descendants

Showing 5 of 86 · 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
  • K013331Lympha Press Plus DeviceMego Afek · 2001 · cites it directly26descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K810338Lympha PressMego Afek1981—
+1K013436Normatec PCDNormatec, Inc.2001—
+2K112890Normatec MVPNormaTec Industries, LP2012—
+3K160608NormaTec Pulse and NormaTec Pulse ProNormaTec Industries, LP2016—
+4K182668Rapid Reboot Compression Therapy SystemRapid Reboot Recovery Products, LLC2018—
+1K013331Lympha Press Plus DeviceMego Afek2001—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200120
200410
200720
200810
201020
201110
201220
201320
201520
201630
201710
201850
201940
202070
2021130
2022130
202340
202470
202580
202660
FIG. 1 — Lineage of K810338, 1981–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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. #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
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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? (86)

See all 86

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

NumberDeviceApplicantDecidedDescendants
K013436Normatec PCDNormatec, Inc.200155
K013331Lympha Press Plus DeviceMego Afek200126
K041659C-BOOTC-Boot, Ltd.20042

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

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—

More from Mego Afek

5 FDA decisions under this applicant name. See the company

  • K230385Ballancer Platinum (1222)Mego Afek · 2023
  • K072372Phlebopress Model 601A Compression Therapy DeviceMego Afek · 2007
  • K060220PBS Model 701A Compression Therapy DeviceMego Afek · 2006
  • K013331Lympha Press Plus DeviceMego Afek · 2001

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/K810338 · printed Nov 6, 2026

Cite this page

510(k) Report. “K810338: Lympha Press.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K810338

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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