FDA product code JOW: Sleeve, Limb, Compressible
JOW is the FDA product code for sleeve, limb, compressible. It is a Class II device, regulated under 21 CFR 870.5800 and reviewed by the Cardiovascular panel. FDA has cleared 354 510(k) submissions under JOW, 34 in the last five years, from 169 different applicants. The average 510(k) review took 148 days (median 126); 215 days on average over the last three years. FDA has posted 32 recalls for JOW devices, 4 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Sleeve, Limb, Compressible |
| Device class | Class II |
| Regulation | 21 CFR 870.5800 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for JOW
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 9 | 115 |
| 2018 | 11 | 162 |
| 2019 | 11 | 96 |
| 2020 | 14 | 155 |
| 2021 | 16 | 143 |
| 2022 | 7 | 99 |
| 2023 | 6 | 162 |
| 2024 | 8 | 212 |
| 2025 | 7 | 202 |
| 2026 | 6 | 230 |
Compare with all 510(k) review times · Search every JOW clearance
Top JOW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bio Compression Systems, Inc. | 12 | 2026-09-11 |
| Mego Afek AC , Ltd. | 11 | 2022-04-14 |
| Medical Compression Systems (Dbn) , Ltd. | 9 | 2016-07-13 |
| Hygia Health Services, Inc. | 9 | 2009-04-22 |
| Airos Medical, Inc. | 7 | 2024-10-11 |
164 more applicants have JOW clearances. See the full list in Caduvo.
Most recent JOW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261807 | Bio Compression Systems, Inc. | Sequential Circulator (SC-4004-DL, SC-4008-DL) | 2026-09-11 | 102 |
| K254217 | Evolym, LLC | Aerloom | 2026-08-31 | 245 |
| K253555 | Tactile Medical | Flexitouch® Plus Advanced Pneumatic Compression System | 2026-07-31 | 259 |
| K253386 | Vistar Medical Supplies Co., Ltd. | DVT Garment | 2026-06-25 | 268 |
| K250242 | Guangzhou Longest Medical Technology Co., Ltd. | Compression Therapy Device (LGT-2202DVT) | 2026-04-24 | 452 |
Recalls for JOW devices
32 product recalls in 17 recall events; 4 initiated in the last five years and 4 still open. Most recent: 2025-05-13.
| Year | Recalls |
|---|---|
| 2017 | 2 |
| 2019 | 8 |
| 2021 | 2 |
| 2023 | 1 |
| 2025 | 3 |
Frequently asked questions
What is FDA product code JOW?
JOW is the FDA product code for sleeve, limb, compressible. It is a Class II device, regulated under 21 CFR 870.5800 and reviewed by the Cardiovascular panel.
What device class is JOW?
Class II, regulation 21 CFR 870.5800. Typical premarket route: 510(k).
How long does a 510(k) take for product code JOW?
Across 354 cleared submissions the average was 148 days from receipt to decision (median 126).
Which companies have the most JOW clearances?
Bio Compression Systems, Inc. (12); Mego Afek AC , Ltd. (11); Medical Compression Systems (Dbn) , Ltd. (9); Hygia Health Services, Inc. (9); Airos Medical, Inc. (7).
Have JOW devices been recalled?
Yes: 32 product recalls across 17 recall events; the most recent began 2025-05-13.
Next steps
- Run an FDA pathway report with predicate devices for product code JOW
- Run a recall and safety report across every JOW manufacturer
- Watch product code JOW for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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