# K213533: Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL

- Pathway: 510(k) (Traditional)
- Applicant: Bio Compression Systems, Inc.
- Decided: Feb 16, 2022 after 103 days
- Product code: IRP (Massager, Powered Inflatable Tube)
- Device class: 2
- Regulation: 21 CFR 890.5650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K112479 (2011). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122112: 2004-OC Massage System, 2008-OC Massage System, Bio Compression Systems, Inc. (2013) Summary page 4.

## Indications for use
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.

Source page: https://510kreport.com/device/K213533
Methodology: https://510kreport.com/methodology