510(k) · Cleared
Cleared2004-OC Massage System, 2008-OC Massage System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio Compression Systems, Inc. · IRP Massager, Powered Inflatable Tube
Cleared on Apr 9, 2013 as substantially equivalent to K112479 (Mego Afek AC, Ltd., 2011) after a 266-day review. Its family tree reaches back 1 generation to 2011. 2 later devices descend from it.
- Decided
- Apr 9, 2013
- Review
- 266 days
- Class
- Class II
- Product code
- IRP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K112479 (2011). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK112479 DSJ MassagerMego Afek AC, Ltd. · 2011
- This deviceK122112 2004-OC Massage System, 2008-OC Massage SystemBio Compression Systems, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK213533 Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL…Bio Compression Systems, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK201645 Massage Compression BootsJkh USA, LLC · 2020
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K112479 | DSJ Massager | Mego Afek AC, Ltd. | 2011 | — |
| 0 (this device) | K122112 | 2004-OC Massage System, 2008-OC Massage System | Bio Compression Systems, Inc. | 2013 | — |
| +1 | K213533 | Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL… | Bio Compression Systems, Inc. | 2022 | — |
| +1 | K201645 | Massage Compression Boots | Jkh USA, LLC | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2022 | 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 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? (1)
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 |
|---|---|---|---|
| * | K112479 | DSJ MassagerSummary page 1…le Tube Massager Devices are classified as Class 11devices, and reviewed by the Division of Surgical, Orthopedic and Restorative Devices. PREDICATE DEVICE DJS Massager (K1 12479; product code IRP) manufactured by Mego Afec AC LTD. DEVICE DESCRIPTION The device consists of an air compressor with manually a… | 2011 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All IRP devicesIRP Massager, Powered Inflatable Tube: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
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 2004-00 and 2008-0C Massage Systems are powered inflatable tube massagers
intended to temporarily relieve minor muscle aches and/or pains, and to temporarily
increase circulation to the treated areas. The devices are intended for home use by
people who are in good health.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122112 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122112: 2004-OC Massage System, 2008-OC Massage System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122112
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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