510(k) · Cleared
ClearedPulsatile Anti-Embolism Sys.Pump
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baxter Healthcare Corp · JOW Sleeve, Limb, Compressible
Cleared on Jul 22, 1991 after an 87-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 56 later devices descend from it.
- Decided
- Jul 22, 1991
- Review
- 87 days
- Class
- Class II
- Product code
- JOW
- Recalls
- None
- Predicates
- 0
56 later devices descend from it, 1 citing it directly.
- This deviceK911853 Pulsatile Anti-Embolism Sys.PumpBaxter Healthcare Corp · 1991
- Descendant · cites it directly · 55 of its ownK013436 Normatec PCDNormatec, Inc. · 2001
- Descendant · 2 generations on · 52 of its ownK112890 Normatec MVPNormaTec Industries, LP · 2012
- Descendant · 3 generations on · 51 of its ownK160608 NormaTec Pulse and NormaTec Pulse ProNormaTec Industries, LP · 2016
- Descendant · 4 generations on · 38 of its ownK182668 Rapid Reboot Compression Therapy SystemRapid Reboot Recovery Products, LLC · 2018
- Descendant · 4 generations on · 20 of its ownK193354 Air Compression Therapy DeviceShenzhen Dongjilian Electronics Co., Ltd. · 2020
Showing 5 of 56 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 56 · 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
- K193354Air Compression Therapy DeviceShenzhen Dongjilian Electronics Co., Ltd. · 2020 · 4 generations on20descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K911853 | Pulsatile Anti-Embolism Sys.Pump | Baxter Healthcare Corp | 1991 | — |
| +1 | K013436 | Normatec PCD | Normatec, Inc. | 2001 | — |
| +2 | K112890 | Normatec MVP | NormaTec Industries, LP | 2012 | — |
| +3 | K160608 | NormaTec Pulse and NormaTec Pulse Pro | NormaTec Industries, LP | 2016 | — |
| +4 | K182668 | Rapid Reboot Compression Therapy System | Rapid Reboot Recovery Products, LLC | 2018 | — |
| +4 | K193354 | Air Compression Therapy Device | Shenzhen Dongjilian Electronics Co., Ltd. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2012 | 1 | 0 |
| 2016 | 2 | 0 |
| 2018 | 3 | 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), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (56)
See all 561 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K013436 | Normatec PCD | 2001 | 55 |
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 devicesJOW Sleeve, Limb, Compressible: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K911853 · printed Nov 6, 2026
Cite this page
510(k) Report. “K911853: Pulsatile Anti-Embolism Sys.Pump.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K911853
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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