510(k) · Cleared
ClearedAtlant's
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Grad-Line Corp. · IRP Massager, Powered Inflatable Tube
Cleared on Oct 22, 1998 after a 335-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 4 later devices descend from it.
- Decided
- Oct 22, 1998
- Review
- 335 days
- Class
- Class II
- Product code
- IRP
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK974395 Atlant'sGrad-Line Corp. · 1998
- Descendant · cites it directly · 3 of its ownK053225 Cellu M6 Keymodule ILpg One, Inc. · 2006
- Descendant · 2 generations on · 2 of its ownK092734 E-Light LineEspansione Marketing S.P.A · 2010
- Descendant · 3 generations on · 1 of its ownK124064 Young AgainEspansione Marketing S.P.A · 2013
- Descendant · 4 generations on · 0 of its ownK162556 Lightfusion Led SystemVitage Led, Ltd. · 2017
Most influential descendants
Showing 4 of 4 · See all- K053225Cellu M6 Keymodule ILpg One, Inc. · 2006 · cites it directly3descendants
- K092734E-Light LineEspansione Marketing S.P.A · 2010 · 2 generations on2descendants
- K124064Young AgainEspansione Marketing S.P.A · 2013 · 3 generations on1descendant
- K162556Lightfusion Led SystemVitage Led, Ltd. · 2017 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K974395 | Atlant's | Grad-Line Corp. | 1998 | — |
| +1 | K053225 | Cellu M6 Keymodule I | Lpg One, Inc. | 2006 | — |
| +2 | K092734 | E-Light Line | Espansione Marketing S.P.A | 2010 | — |
| +3 | K124064 | Young Again | Espansione Marketing S.P.A | 2013 | — |
| +4 | K162556 | Lightfusion Led System | Vitage Led, Ltd. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2017 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K053225 | Cellu M6 Keymodule I | 2006 | 3 |
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, K053225 (Lpg One, Inc., 2006) has gone furthest, with 3 descendants of its own.
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?
For the treatment of chronic venous insufficiency, lymphedema, edema of venous origin, post amputation, lymphatic obstruction and contusions.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K974395 · printed Nov 6, 2026
Cite this page
510(k) Report. “K974395: Atlant's.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974395
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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