510(k) · Cleared
ClearedSun Scientific LLC-Leg Compressor and Pfab
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sun Scientific, LLC · MHW Dressing, Compression
Cleared on May 16, 2007 as substantially equivalent to K883224 (Graham-Field, Inc., 1989) and 3 other predicates after an 89-day review. Its family tree reaches back 2 generations to 1981.
- Decided
- May 16, 2007
- Review
- 89 days
- Class
- Class I
- Product code
- MHW
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K810338 (1981). 6 ancestors in all. No later device cites it as a predicate yet.
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 | K041659 | C-BOOT | C-Boot, Ltd. | 2004 | — |
| 0 (this device) | K070457 | Sun Scientific LLC-Leg Compressor and Pfab | Sun Scientific, LLC | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 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 MHW? 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? (5)
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 |
|---|---|---|---|
| * | K883224 | Unna Boot Dressing W/CalamineSummary page 2…AVJ [. 6L,5 '7 Predicate Device 121 CFR 807.92(a)(3)1 The subject device is most similar to the following types of devices: Unna Boot Dressing by Graham Field - K883224 Unna Sleeve by ACI Medical - K903532 Unna Flex Elastic Unna Boot by Convatec - Exempt from 510(k), classified as "FQM" Hydrasorb… | 1989 |
| * | K903532 | Unna-Sleeve (TM)Summary page 2…ice 121 CFR 807.92(a)(3)1 The subject device is most similar to the following types of devices: Unna Boot Dressing by Graham Field - K883224 Unna Sleeve by ACI Medical - K903532 Unna Flex Elastic Unna Boot by Convatec - Exempt from 510(k), classified as "FQM" Hydrasorb Sterile Dressing by Avitar - K973260… | 1990 |
| * | K973260 | Hydrasorb Sterile DressingSummary page 2…d - K883224 Unna Sleeve by ACI Medical - K903532 Unna Flex Elastic Unna Boot by Convatec - Exempt from 510(k), classified as "FQM" Hydrasorb Sterile Dressing by Avitar - K973260 C-Boot - K041659 Description of the Device [21 CFR 807.92(a)(4)1 The device includes a Leg Compressor and a Pre-Fille… | 1997 |
| * | K041659 | C-BOOTSummary page 2…Sleeve by ACI Medical - K903532 Unna Flex Elastic Unna Boot by Convatec - Exempt from 510(k), classified as "FQM" Hydrasorb Sterile Dressing by Avitar - K973260 C-Boot - K041659 Description of the Device [21 CFR 807.92(a)(4)1 The device includes a Leg Compressor and a Pre-Filled Air Bladder (PF… | 2004 |
| * | — | Unna Flex Elastic Unna Boot by Convatec Named without a submission number |
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 26 years and passes through 3 companies; a new generation was cleared every 23.0 years on median.
- None of the 6 ancestors has a recall.
How does its category compare?
All MHW devicesMHW Dressing, Compression: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · MHW
1in 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · MHW
Too few MHW 510(k)s in any year since 2007 to give a median.
Recalls per year · MHW
1so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MHW
1in 2025
MAUDE reports naming product code MHW, 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 | 6 |
| 2008 | 0 | — | 0 | 5 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 12 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 3 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
To assist in the management of venous stasis ulcers by applying pressure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070457 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070457: Sun Scientific LLC-Leg Compressor and Pfab.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070457
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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