510(k) Report

510(k) · Cleared

Cleared

Normatec PCD

K013436510(k) TraditionalCleared Dec 21, 200166-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

Normatec, Inc. · JOW Sleeve, Limb, Compressible

Cleared on Dec 21, 2001 as substantially equivalent to K935998 (Camp Intl., Inc., 1995) and 4 other predicates after a 66-day review. Its family tree reaches back 1 generation to 1981. 55 later devices descend from it.

Decided
Dec 21, 2001
Review
66 days
Class
Class II
Product code
JOW
Recalls
None
Predicates
5

Its longest line of descent runs back 1 generation to K810338 (1981). 5 ancestors in all. 55 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1995: 1 other ancestor1992: 1 other ancestor1991: 1 other ancestor1983: 1 other ancestor2012: 1 descendant cleared2016: 2 descendants cleared2018: 3 descendants cleared2020: 4 descendants cleared2021: 12 descendants cleared2019: 2 descendants cleared2023: 3 descendants cleared2022: 11 descendants cleared2025: 6 descendants cleared2026: 5 descendants cleared2024: 6 descendants clearedK810338 · Lympha Press · Mego Afek · 198119801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors 1 generation forward: 2 descendants2 generations forward: 2 descendants3 generations forward: 8 descendants4 generations forward: 26 descendants5 generations forward: 12 descendants6 generations forward: 5 descendants K810338 · Lympha Press · Mego Afek · 19810+5
  1. Root · 1 generation backK810338 Lympha PressMego Afek · 1981
  2. This deviceK013436 Normatec PCDNormatec, Inc. · 2001
  3. Descendant · cites it directly · 52 of its ownK112890 Normatec MVPNormaTec Industries, LP · 2012
  4. Descendant · 2 generations on · 51 of its ownK160608 NormaTec Pulse and NormaTec Pulse ProNormaTec Industries, LP · 2016
  5. Descendant · 3 generations on · 38 of its ownK182668 Rapid Reboot Compression Therapy SystemRapid Reboot Recovery Products, LLC · 2018
  6. Descendant · 3 generations on · 20 of its ownK193354 Air Compression Therapy DeviceShenzhen Dongjilian Electronics Co., Ltd. · 2020
  7. Descendant · 3 generations on · 10 of its ownK183169 Pulse 2.0, Pulse Pro 2.0NormaTec Industries, LP · 2018

Showing 5 of 55 descendants. See all descendants

Descendants cleared per year

2012: 12016: 22018: 32019: 22020: 42021: 122022: 112023: 32024: 62025: 62026: 5
2012high 12 (2021) · low 0 (2013)2026

Most influential descendants

Showing 5 of 55 · See all
  • K112890Normatec MVPNormaTec Industries, LP · 2012 · cites it directly52descendants
  • K160608NormaTec Pulse and NormaTec Pulse ProNormaTec Industries, LP · 2016 · 2 generations on51descendants
  • K182668Rapid Reboot Compression Therapy SystemRapid Reboot Recovery Products, LLC · 2018 · 3 generations on38descendants
  • K193354Air Compression Therapy DeviceShenzhen Dongjilian Electronics Co., Ltd. · 2020 · 3 generations on20descendants
  • K183169Pulse 2.0, Pulse Pro 2.0NormaTec Industries, LP · 2018 · 3 generations on10descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K810338Lympha PressMego Afek1981—
0 (this device)K013436Normatec PCDNormatec, Inc.2001—
+1K112890Normatec MVPNormaTec Industries, LP2012—
+2K160608NormaTec Pulse and NormaTec Pulse ProNormaTec Industries, LP2016—
+3K182668Rapid Reboot Compression Therapy SystemRapid Reboot Recovery Products, LLC2018—
+3K193354Air Compression Therapy DeviceShenzhen Dongjilian Electronics Co., Ltd.2020—
+3K183169Pulse 2.0, Pulse Pro 2.0NormaTec Industries, LP2018—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198310
199110
199210
199510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
201620
201830
201920
202040
2021120
2022110
202330
202460
202560
202650
FIG. 1 — Lineage of K013436, 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), 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. #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
Get a 510(k) Report

What was it cleared against? (5)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K935998Enterprise
Summary page 1
…ke E. Norriton, PA 19401 Common or Usual Name Noninvasive pneumatic compression device Classification Name Compressible Limb Sleeve Predicate Devices Camp GCS 2000 (K935998), Wright Linear Pump (K830577), Talley Multicom 500 (K915637), Mego Afek Lymphapress (K810338), and Baxter Pulsatile Anti-Embolis…
Camp Intl., Inc.1995—
*K830577Linear Pump #4370975
Summary page 1
…on or Usual Name Noninvasive pneumatic compression device Classification Name Compressible Limb Sleeve Predicate Devices Camp GCS 2000 (K935998), Wright Linear Pump (K830577), Talley Multicom 500 (K915637), Mego Afek Lymphapress (K810338), and Baxter Pulsatile Anti-Embolism System Pump (PAS II) (K91185…
Wright Linear Pump, Inc.1983—
*K915637Talley TM500 Sequential Multicom Compression Syst.
Summary page 1
…neumatic compression device Classification Name Compressible Limb Sleeve Predicate Devices Camp GCS 2000 (K935998), Wright Linear Pump (K830577), Talley Multicom 500 (K915637), Mego Afek Lymphapress (K810338), and Baxter Pulsatile Anti-Embolism System Pump (PAS II) (K911853). Intended Use The NormaTec…
Progressive Medical Technology, Inc.1992—
*K810338Lympha Press
Summary page 1
…ification Name Compressible Limb Sleeve Predicate Devices Camp GCS 2000 (K935998), Wright Linear Pump (K830577), Talley Multicom 500 (K915637), Mego Afek Lymphapress (K810338), and Baxter Pulsatile Anti-Embolism System Pump (PAS II) (K911853). Intended Use The NormaTec PCD is intended to be used to ap…
Mego Afek1981—
*K911853Pulsatile Anti-Embolism Sys.Pump
Summary page 1
…CS 2000 (K935998), Wright Linear Pump (K830577), Talley Multicom 500 (K915637), Mego Afek Lymphapress (K810338), and Baxter Pulsatile Anti-Embolism System Pump (PAS II) (K911853). Intended Use The NormaTec PCD is intended to be used to apply pressure to the extremities. The NormaTec PCD is indicated for…
Baxter Healthcare Corp1991—

What descends from it? (55)

See all 55

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

NumberDeviceApplicantDecidedDescendants
K112890Normatec MVPNormaTec Industries, LP201252
K161346NormaTec PCD-T and PCD-BNormaTec Industries, LP20161

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?

  • None of the 5 ancestors has a recall.
  • Of its descendants, K112890 (NormaTec Industries, LP, 2012) has gone furthest, with 52 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—

What is it indicated for?

The NormaTec PCD is intended to apply pressure to the extremities to treat:

Lymphedema and other edematous conditions, including

Congenital lymphedema (Millroy’s disease, lymphedema praecox,

and lymphedema tarda)

Post-mastectomy lymphedema

Post-infection lymphedema

Post-traumatic lymphedema

Post-surgical lymphedema

Post-radiation-treatment lymphedema

Venous insufficiency

Venous stasis ulceration

and to prevent:

Deep Vein Thrombosis

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

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/K013436 · printed Nov 4, 2026

Cite this page

510(k) Report. “K013436: Normatec PCD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013436

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026