510(k) · Cleared
ClearedHydroboot
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Incappe, Inc. · DWL Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)
Cleared on Aug 12, 2002 as substantially equivalent to K981296 (Geen Healthcare, Inc., 1998) and 2 other predicates after a 33-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- Aug 12, 2002
- Review
- 33 days
- Class
- Class II
- Product code
- DWL
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K963573 (1996). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK963573 ElvarexJobst A Beiersdorf Co. · 1996
- This deviceK022233 HydrobootIncappe, Inc. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K963573 | Elvarex | Jobst A Beiersdorf Co. | 1996 | — |
| 0 (this device) | K022233 | Hydroboot | Incappe, Inc. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2002 | 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 DWL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K981296 | Geen MedisoxSummary page 1…Henk Kuiper, Prepared: July 5, 2002 A. LEGALLY MARKETED PREDICATE DEVICES The Hydroboot is substantially equivalent to: the Geen Medisox, cleared by FDA as K98 1296 on May 29, 1998; to the Jobst Elvarex Compression Garment, cleared by FDA as K963573 on October 16, 1996; and, to the Pneuma… | 1998 |
| * | K963573 | ElvarexSummary page 1…oboot is substantially equivalent to: the Geen Medisox, cleared by FDA as K98 1296 on May 29, 1998; to the Jobst Elvarex Compression Garment, cleared by FDA as K963573 on October 16, 1996; and, to the Pneumatic Ambulatory Compression System, cleared by FDA as KO20538 on May 15, 2002. B. D… | 1996 |
| * | K020538 | Boehringer Laboratories Pneumatic Ambulatory Compression System 8200 Series | 2002 |
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.
How does its category compare?
All DWL devicesDWL Stocking, Medical Support (To Prevent Pooling Of Blood In Legs): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DWL
1in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · DWL
111in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DWL
No recall names DWL since 2007.
Adverse event reports per year · DWL
2in 2025
MAUDE reports naming product code DWL, 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 | 1 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 3 |
| 2010 | 3 | 214 | 0 | 7 |
| 2011 | 2 | — | 0 | 4 |
| 2012 | 5 | 43 | 0 | 10 |
| 2013 | 3 | 111 | 0 | 4 |
| 2014 | 1 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 4 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 3 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The HydroBoot provides comprehensive therapy on the lower legs and feet to help manage chronic swelling and ulceration due to venous insufficiency and lymphedema.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022233 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022233: Hydroboot.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022233
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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