510(k) · Cleared
ClearedNormaTec PCD-T and PCD-B
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
NormaTec Industries, LP · JOW Sleeve, Limb, Compressible
Cleared on Jun 15, 2016 as substantially equivalent to K013436 (Normatec, Inc., 2001) after a 30-day review. Its family tree reaches back 2 generations to 1981. 1 later device descends from it.
- Decided
- Jun 15, 2016
- Review
- 30 days
- Class
- Class II
- Product code
- JOW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K810338 (1981). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK810338 Lympha PressMego Afek · 1981
- 1 generation backK013436 Normatec PCDNormatec, Inc. · 2001
- This deviceK161346 NormaTec PCD-T and PCD-BNormaTec Industries, LP · 2016
- Descendant · cites it directly · 0 of its ownK183328 Pulse Rx 2.0, Pulse Pro Rx 2.0NormaTec Industries, LP · 2018
Most influential descendants
Showing 1 of 1 · See all- K183328Pulse Rx 2.0, Pulse Pro Rx 2.0NormaTec Industries, LP · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K810338 | Lympha Press | Mego Afek | 1981 | — |
| −1 | K013436 | Normatec PCD | Normatec, Inc. | 2001 | — |
| 0 (this device) | K161346 | NormaTec PCD-T and PCD-B | NormaTec Industries, LP | 2016 | — |
| +1 | K183328 | Pulse Rx 2.0, Pulse Pro Rx 2.0 | NormaTec Industries, LP | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
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 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
What was it cleared against? (1)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K013436 | Normatec PCDSummary page 4…ressible limb sleeve. Class II Device Name: NormaTec PCD-T and NormaTec PCD-B Predicate Devices: K013436 – NormaTec PCD Device Description: The NormaTec PCD-T and PCD-B are designed to provide noninvasive air compression therapy fo… | 2001 |
| † | K160608 | NormaTec Pulse and NormaTec Pulse Pro | 2016 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K183328 | Pulse Rx 2.0, Pulse Pro Rx 2.0 | 2018 | 0 |
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?
- The line of descent spans 35 years and passes through 3 companies; a new generation was cleared every 20.2 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K183328 (NormaTec Industries, LP, 2018) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K013436.
How does its category compare?
All JOW devicesJOW 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
2026 to Oct 25, outlined.
Median 510(k) review, days · JOW
168in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JOW
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JOW
24in 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 NormaTec PCD-T and NormaTec PCD-B are 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 as stated in the FDA summary.
https://510kreport.com/device/K161346 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161346: NormaTec PCD-T and PCD-B.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161346
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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