Product code JOW: 510(k) clearances and predicates
Product code JOW covers Sequential Circulator (SC-4004-DL, SC-4008-DL). FDA lists 354 clearances under this code in the 510(k) index. This page summarizes recent clearance volume and names recent clearances by K number so you can pick predicates faster.
Clearance volume
354 clearances on file under product code JOW. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 7 |
| 2023 | 6 |
| 2024 | 8 |
| 2025 | 7 |
| 2026 so far | 6 |
Recent clearances
Newest JOW clearances in the FDA index, with applicant and decision date:
- K261807, Sequential Circulator (SC-4004-DL, SC-4008-DL), applicant Bio Compression Systems, Inc., decided 2026-09-11. FDA record
- K254217, Aerloom, applicant Evolym, LLC, decided 2026-08-31. FDA record
- K253555, Flexitouch® Plus Advanced Pneumatic Compression System, applicant Tactile Medical, decided 2026-07-31. FDA record
- K253386, DVT Garment, applicant Vistar Medical Supplies Co., Ltd., decided 2026-06-25. FDA record
- K250242, Compression Therapy Device (LGT-2202DVT), applicant Guangzhou Longest Medical Technology Co., Ltd., decided 2026-04-24. FDA record
- K254267, NanoPress 760A-BT (760A-BT), applicant Mego Afek , Ltd., decided 2026-02-24. FDA record
- K250974, Bio Arterial Deluxe (IC-BAP-DX), applicant Bio Compression Systems, Inc., decided 2025-12-12. FDA record
- K250190, Sequential Compression System (SCD600), applicant Shenzhen Comen Medical Instruments Co.,Ltd, decided 2025-12-08. FDA record
What this means for a regulatory watcher
Volume tells you how deep the predicate pool is. A code with steady yearly counts gives you many candidate predicates, which helps when one predicate has a recall or design gap. A code with a sharp recent rise means reviewers are seeing more of this device type, so substantial equivalence arguments need to track the newest cleared devices, not five year old ones. Related device names in recent clearances include Aerloom, Flexitouch® Plus Advanced Pneumatic Compression System. Watch new JOW clearances as they post: each one is a possible predicate for your submission and a possible competitor worth reading.
FAQ
What is FDA product code JOW?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent JOW clearances include Sequential Circulator (SC-4004-DL, SC-4008-DL).
How many 510(k) clearances use product code JOW?
354 at the time this page was generated, from openFDA records.
How do I find a predicate device under JOW?
Start with the recent K numbers listed above, then run the free predicate search to check substantial equivalence text and review history.
How do I track new JOW clearances?
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.