510(k) · Cleared
ClearedSequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL
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 Feb 16, 2022 as substantially equivalent to K122112 (Bio Compression Systems, Inc., 2013) after a 103-day review. Its family tree reaches back 2 generations to 2011.
- Decided
- Feb 16, 2022
- Review
- 103 days
- Class
- Class II
- Product code
- IRP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K112479 (2011). 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 | K112479 | DSJ Massager | Mego Afek AC, Ltd. | 2011 | — |
| −1 | K122112 | 2004-OC Massage System, 2008-OC Massage System | Bio Compression Systems, Inc. | 2013 | — |
| 0 (this device) | K213533 | Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL… | Bio Compression Systems, Inc. | 2022 | — |
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 |
|---|---|---|---|
| * | K122112 | 2004-OC Massage System, 2008-OC Massage SystemSummary page 4…atable tube massager (21 CFR 890.5650) Product Code IRP Class Class II III. PREDICATE DEVICE 2004-OC Massage System, 2008-OC Massage System (K122112). Reference devices K030437, K122154, K133483, K160608, K183169, and K210967 are mentioned.… | 2013 |
| † | K030437 | Relaxor Perfect Touch Air Massaging System | 2003 |
| † | K122154 | Powerplay Muscle Massager | 2012 |
| † | K133483 | Portable Therapeutix Squid Active Cold Compression Device and Cold Pack for Otc Use | 2014 |
| † | K160608 | NormaTec Pulse and NormaTec Pulse Pro | 2016 |
| † | K183169 | Pulse 2.0, Pulse Pro 2.0 | 2018 |
| † | K210967 | Air Pressure Therapy System: VU-IPC06 | 2021 |
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 11 years and passes through 2 companies; a new generation was cleared every 8.9 years on median.
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K122112.
How does its category compare?
All IRP devicesIRP Massager, Powered Inflatable Tube: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
Intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated area in people who are in good health.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K213533 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213533: Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213533
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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