510(k) · Cleared
ClearedInarex, Model 2D-LX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inarex Corporation · JFB Table, Physical Therapy, Multi Function
Cleared on Aug 27, 2008 as substantially equivalent to K040031 (Ceragem Co., Ltd., 2004) and 1 other predicate after a 181-day review. Its family tree reaches back 5 generations to 2000. 1 later device descends from it.
- Decided
- Aug 27, 2008
- Review
- 181 days
- Class
- Class II
- Product code
- JFB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K993461 (2000). 6 ancestors in all, the oldest K933443 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK993461 Quest Intersegmental Roller Traction TableIcon Intl., LLC · 2000
- 4 generations backK002390 Quantum Intersegmental Traction Table 400, 401, 400H,401HLsi Intl., Inc. · 2000
- 3 generations backK032449 Thermassage Energy Product, Model HY5000Migun Medical Instrument Co., Ltd. · 2003
- 2 generations backK040031 Ceragem-C Thermal Acupressure MassagerCeragem Co., Ltd. · 2004
- 1 generation backK062476 Ceragem RH1 Automatic Thermal MassagerCeragem International, Inc. · 2006
- This deviceK080554 Inarex, Model 2D-LXInarex Corporation · 2008
- Descendant · cites it directly · 0 of its ownK102281 Thermal Massage Bed, Model 2D-GXInarex Corporation · 2010
Most influential descendants
Showing 1 of 1 · See all- K102281Thermal Massage Bed, Model 2D-GXInarex Corporation · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K993461 | Quest Intersegmental Roller Traction Table | Icon Intl., LLC | 2000 | — |
| −4 | K002390 | Quantum Intersegmental Traction Table 400, 401, 400H,401H | Lsi Intl., Inc. | 2000 | — |
| −3 | K032449 | Thermassage Energy Product, Model HY5000 | Migun Medical Instrument Co., Ltd. | 2003 | — |
| −2 | K040031 | Ceragem-C Thermal Acupressure Massager | Ceragem Co., Ltd. | 2004 | — |
| −1 | K062476 | Ceragem RH1 Automatic Thermal Massager | Ceragem International, Inc. | 2006 | — |
| 0 (this device) | K080554 | Inarex, Model 2D-LX | Inarex Corporation | 2008 | — |
| +1 | K102281 | Thermal Massage Bed, Model 2D-GX | Inarex Corporation | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 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 JFB? 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 JFB device
- #1 K240168 N7-Sscore 9.8 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K040031 | Ceragem-C Thermal Acupressure MassagerSummary page 1…-Common/Usual Name: Thermal Massage Bed 2. Equivalent legally marketed device: This product is similar in design and identical in function to the Ceragem-C (K040031, CERAGEM CO., LTD.), Ceragem-RH1 (K062476, CERAGEM CO., LTD.) 3. Indications for Use (intended use): Thermal Massage… | 2004 |
| * | K062476 | Ceragem RH1 Automatic Thermal MassagerSummary page 1…2. Equivalent legally marketed device: This product is similar in design and identical in function to the Ceragem-C (K040031, CERAGEM CO., LTD.), Ceragem-RH1 (K062476, CERAGEM CO., LTD.) 3. Indications for Use (intended use): Thermal Massage Bed (2D-LX) is a device intended to provid… | 2006 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K102281 | Thermal Massage Bed, Model 2D-GX | 2010 | 0 |
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 8 years and passes through 6 companies; a new generation was cleared every 1.8 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K102281 (Inarex Corporation, 2010) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K040031.
How does its category compare?
All JFB devicesJFB Table, Physical Therapy, Multi Function: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · JFB
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JFB
162in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JFB
No recall names JFB since 2007.
Adverse event reports per year · JFB
1in 2024
MAUDE reports naming product code JFB, 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 | 3 |
| 2008 | 1 | — | 0 | 3 |
| 2009 | 0 | — | 0 | 3 |
| 2010 | 2 | — | 0 | 1 |
| 2011 | 2 | — | 0 | 1 |
| 2012 | 2 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 2 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 2 | — | 0 | 1 |
| 2025 | 3 | 162 | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Thermal Massage Bed (2D-LX) is a device intended to provide patients with muscle relaxation therapy by delivering heat and smoothing massage. Additionally, the thermal lamps provide topical heating for:
* Temporary relief of minor muscle and joint pain, and stiffness
* Temporary relief of minor joint pain associated with arthritis
* Temporary increase in local circulation where applied
* Relaxation of muscles:
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080554 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080554: Inarex, Model 2D-LX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080554
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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