510(k) · Cleared
ClearedSlendair 4000 Compression System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Compression Systems (Dbn), Ltd. · IRP Massager, Powered Inflatable Tube
Cleared on Mar 3, 2000 as substantially equivalent to K915092 (Progressive Medical Technology, Inc., 1992) and 2 other predicates after a 94-day review. Its family tree reaches back 1 generation to 1992.
- Decided
- Mar 3, 2000
- Review
- 94 days
- Class
- Class II
- Product code
- IRP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K915092 (1992). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK915092 Talley TM300 Sequential Multicom Compression SystProgressive Medical Technology, Inc. · 1992
- This deviceK994057 Slendair 4000 Compression SystemMedical Compression Systems (Dbn), Ltd. · 2000
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K915092 | Talley TM300 Sequential Multicom Compression Syst | Progressive Medical Technology, Inc. | 1992 | — |
| 0 (this device) | K994057 | Slendair 4000 Compression System | Medical Compression Systems (Dbn), Ltd. | 2000 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 2 | 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 |
|---|---|---|---|
| * | K915092 | Talley TM300 Sequential Multicom Compression SystSummary page 2…anel. 8-3 VS TNE /r’; 2w Predicate Device: ¢ Talley TM300 Sequential Multicom Compression System (Progressive Medical Technology, Inc.), cleared under K915092; * Talley TM500 Sequential Multicom Compression System (Progressive Medical Technology, Inc.) cleared under K915637. * Talley M… | 1992 |
| * | K915637 | Talley TM500 Sequential Multicom Compression Syst.Summary page 2…Progressive Medical Technology, Inc.), cleared under K915092; * Talley TM500 Sequential Multicom Compression System (Progressive Medical Technology, Inc.) cleared under K915637. * Talley Multipulse Sequential Compression Unit (Progressive Medical Technology, Inc.) cleared under K914774. L] Performance… | 1992 |
| * | K914774 | Multipulse Sequential Compression UnitSummary page 2…ystem (Progressive Medical Technology, Inc.) cleared under K915637. * Talley Multipulse Sequential Compression Unit (Progressive Medical Technology, Inc.) cleared under K914774. L] Performance Standards: No performance standards have been established for such device under Section 514 of the Federal Foo… | 1992 |
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?
- None of the 3 ancestors has a recall.
- 2 other devices also cite its predicate K915092.
How does its category compare?
All IRP devicesIRP Massager, Powered Inflatable Tube: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 SlendAir 4000 is a prescriptive device that induces controlled compression of the calf, the leg or the arm.
The SlendAir 4000 is intended for use by medical professionals and patients at home in treating many conditions, such as:
Primary lymphoedema
Post mastectomy edema
Leg ulcers
Edema following trauma and sport injuries
Post immobilization edema
Venous insufficiencies
Lymphoedema
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K994057 · printed Nov 4, 2026
Cite this page
510(k) Report. “K994057: Slendair 4000 Compression System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K994057
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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