510(k) · Cleared
ClearedNormatec MVP
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
NormaTec Industries, LP · IRP Massager, Powered Inflatable Tube
Cleared on Jan 4, 2012 as substantially equivalent to K013436 (Normatec, Inc., 2001) and 2 other predicates after a 96-day review. Its family tree reaches back 2 generations to 1981. 52 later devices descend from it.
- Decided
- Jan 4, 2012
- Review
- 96 days
- Class
- Class II
- Product code
- IRP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K810338 (1981). 8 ancestors in all. 52 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK810338 Lympha PressMego Afek · 1981
- 1 generation backK013436 Normatec PCDNormatec, Inc. · 2001
- This deviceK112890 Normatec MVPNormaTec Industries, LP · 2012
- Descendant · cites it directly · 51 of its ownK160608 NormaTec Pulse and NormaTec Pulse ProNormaTec Industries, LP · 2016
- Descendant · 2 generations on · 38 of its ownK182668 Rapid Reboot Compression Therapy SystemRapid Reboot Recovery Products, LLC · 2018
- Descendant · 2 generations on · 20 of its ownK193354 Air Compression Therapy DeviceShenzhen Dongjilian Electronics Co., Ltd. · 2020
- Descendant · 2 generations on · 10 of its ownK183169 Pulse 2.0, Pulse Pro 2.0NormaTec Industries, LP · 2018
- Descendant · 3 generations on · 7 of its ownK220217 Normatec 3NormaTec Industries, LP · 2022
Showing 5 of 52 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 52 · See all- K160608NormaTec Pulse and NormaTec Pulse ProNormaTec Industries, LP · 2016 · cites it directly51descendants
- K182668Rapid Reboot Compression Therapy SystemRapid Reboot Recovery Products, LLC · 2018 · 2 generations on38descendants
- K193354Air Compression Therapy DeviceShenzhen Dongjilian Electronics Co., Ltd. · 2020 · 2 generations on20descendants
- K183169Pulse 2.0, Pulse Pro 2.0NormaTec Industries, LP · 2018 · 2 generations on10descendants
- K220217Normatec 3NormaTec Industries, LP · 2022 · 3 generations on7descendants
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) | K112890 | Normatec MVP | NormaTec Industries, LP | 2012 | — |
| +1 | K160608 | NormaTec Pulse and NormaTec Pulse Pro | NormaTec Industries, LP | 2016 | — |
| +2 | K182668 | Rapid Reboot Compression Therapy System | Rapid Reboot Recovery Products, LLC | 2018 | — |
| +2 | K193354 | Air Compression Therapy Device | Shenzhen Dongjilian Electronics Co., Ltd. | 2020 | — |
| +2 | K183169 | Pulse 2.0, Pulse Pro 2.0 | NormaTec Industries, LP | 2018 | — |
| +3 | K220217 | Normatec 3 | NormaTec Industries, LP | 2022 | — |
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 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2018 | 2 | 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 |
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 IRP? 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 IRP device
- #1 K193354 Air Compression Therapy Devicescore 28.6 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 PCD | 2001 |
| * | K032505 | Air Press MassagerSummary page 1…Name Powered inflatable tube massager IRP 21 C.F.R. § 890.5650 Predicate Devices NormaTec; PCD (KOI 3436) Telebrand Air Press Massager (K032505) Pneumatic Peripheral Circulation Improvement Device (PPCID) (KOCOBES) Int ended Use I Indications for Use… | 2003 |
| * | K000655 | Ppcid- Pneumatic Peripheral Circulation Improvement (Footrest) DeviceSummary page 2…cal characteristics. The NormaTec MVP and the predicates, the Telebrand Air Press Massager (K032505) and the Pneumatic Peripheral Circulation Improvement Device (PPCID) (K000655), are intended to temporarily relieve minor muscle aches, pains, and to temporarily increase circulation to the treated areas.… | 2001 |
What descends from it? (52)
See all 521 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K160608 | NormaTec Pulse and NormaTec Pulse Pro | 2016 | 51 |
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 31 years and passes through 3 companies; a new generation was cleared every 20.2 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K160608 (NormaTec Industries, LP, 2016) has gone furthest, with 51 descendants of its own.
- 1 other device also cites its predicate K013436.
How does its category compare?
All IRP devicesIRP Massager, Powered Inflatable Tube: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · IRP
13in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IRP
141in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IRP
2in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IRP
10in 2025
MAUDE reports naming product code IRP, 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 | 2 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 2 |
| 2009 | 1 | — | 0 | 1 |
| 2010 | 2 | — | 0 | 5 |
| 2011 | 3 | 164 | 1 | 3 |
| 2012 | 5 | 116 | 0 | 3 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 4 | 113 | 0 | 0 |
| 2015 | 2 | — | 0 | 3 |
| 2016 | 1 | — | 0 | 2 |
| 2017 | 4 | 170 | 2 | 0 |
| 2018 | 3 | 80 | 0 | 0 |
| 2019 | 10 | 83 | 0 | 0 |
| 2020 | 9 | 150 | 0 | 1 |
| 2021 | 19 | 140 | 0 | 0 |
| 2022 | 14 | 97 | 0 | 1 |
| 2023 | 10 | 143 | 0 | 0 |
| 2024 | 12 | 115 | 0 | 4 |
| 2025 | 13 | 141 | 0 | 10 |
| 2026 | 12 | 172 | 0 | — |
What is it indicated for?
The NormaTec MVP is an air pressure massager intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112890 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112890: Normatec MVP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112890
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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