510(k) · Cleared
ClearedPnueAira (PNCU-01)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biotab, LLC · JOW Sleeve, Limb, Compressible
Cleared on Aug 18, 2025 as substantially equivalent to K223195 (Airos Medical, Inc., 2022) and 1 other predicate after a 131-day review. Its family tree reaches back 8 generations to 1981.
- Decided
- Aug 18, 2025
- Review
- 131 days
- Class
- Class II
- Product code
- JOW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K810338 (1981). 15 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK810338 Lympha PressMego Afek · 1981
- 7 generations backK013331 Lympha Press Plus DeviceMego Afek · 2001
- 6 generations backK082149 Lympha Press Optimal, Model# 1201APMego Afek AC, Ltd. · 2008
- 5 generations backK100677 Lympha Press 201MAX, Model 201MAXMego Afek AC, Ltd. · 2010
- 4 generations backK123647 Circuflow 5208 Sequential Compression DeviceDevon Medical, Inc. · 2013
- 3 generations backK172770 AIROS 6 Sequential Compression DeviceAiros Medical, Inc. · 2018
- 2 generations backK193069 AIROS 6 Sequential Compression DeviceAiros Medical, Inc. · 2019
- 1 generation backK223195 AIROS 6P Sequential Compression DeviceAiros Medical, Inc. · 2022
- This deviceK251086 PnueAira (PNCU-01)Biotab, LLC · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K810338 | Lympha Press | Mego Afek | 1981 | — |
| −7 | K013331 | Lympha Press Plus Device | Mego Afek | 2001 | — |
| −6 | K082149 | Lympha Press Optimal, Model# 1201AP | Mego Afek AC, Ltd. | 2008 | — |
| −5 | K100677 | Lympha Press 201MAX, Model 201MAX | Mego Afek AC, Ltd. | 2010 | — |
| −4 | K123647 | Circuflow 5208 Sequential Compression Device | Devon Medical, Inc. | 2013 | — |
| −3 | K172770 | AIROS 6 Sequential Compression Device | Airos Medical, Inc. | 2018 | — |
| −2 | K193069 | AIROS 6 Sequential Compression Device | Airos Medical, Inc. | 2019 | — |
| −1 | K223195 | AIROS 6P Sequential Compression Device | Airos Medical, Inc. | 2022 | — |
| 0 (this device) | K251086 | PnueAira (PNCU-01) | Biotab, LLC | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 2001 | 1 | 0 |
| 2005 | 2 | 0 |
| 2010 | 2 | 0 |
| 2019 | 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? (2)
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 |
|---|---|---|---|
| * | K223195 | AIROS 6P Sequential Compression DeviceSummary page 6…Manufacturer Number Predicate Device AIROS 6P Sequential Compression Device, Airos K223195 X Medical, Inc. K182003 Lympha… | 2022 |
| * | K182003 | Lympha Press Optimal PlusSummary page 6…AIROS 6P Sequential Compression Device, Airos K223195 X Medical, Inc. K182003 Lympha Press Optimal Plus, Mego Afek AC Ltd. X Traditional 510(k) Premarket Not… | 2019 |
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.
What does this lineage say?
- The line of descent spans 44 years and passes through 5 companies; a new generation was cleared every 3.0 years on median.
- None of the 15 ancestors has a recall.
How does its category compare?
All JOW devicesJOW Sleeve, Limb, Compressible: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 PnueAira device and garments for legs and core are intended for use by medical professionals and patients who are under medical supervision to increase lymphatic flow in the treatment of many conditions such as:
• Lymphedema
• Primary lymphedema
• Post mastectomy edema
• Edema following trauma and sports issues
• Post immobilization edema
• Venous insufficiency
• Reducing wound healing time
• Treatment and assistance in healing stasis dermatitis, venous stasis ulcers, arterial ulcers, and diabetic leg ulcers
• Lipedema
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251086 · printed Nov 5, 2026
Cite this page
510(k) Report. “K251086: PnueAira (PNCU-01).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K251086
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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