FDA product code · Cardiovascular
JOWSleeve, Limb, Compressible
Product code JOW covers Sleeve, Limb, Compressible, a Class II device regulated under 21 CFR 870.5800. FDA has cleared 351 devices in this code, 8 of them in the last 12 months. Median review time across the 351 most recent decisions is 126 days. openFDA lists 32 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 870.5800
- Review panel
- Cardiovascular
- Clearances
- 351
What is happening in JOW right now?
JOW (Sleeve, Limb, Compressible) has two findings, most consequential first. 5 first-time filers in the last 12 months, including Vistar Medical Supplies Co., Ltd. and Guangzhou Longest Medical Technology Co., Ltd (K253386, K250242, K250190, K251466, K251086). The code is crowded, scoring 92 of 100 — 158 companies hold a clearance here and 8 arrived in the last 12 months (JOW:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| New entrant | Worth knowing | K253386, K250242, K250190, K251466, K251086 |
| Crowding | Context | JOW:crowding |
Sources checked: predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Composed . Every finding carries the record ids it was derived from; nothing here is an estimate.
How many devices has FDA cleared in JOW?
FDA has cleared 351 devices under product code JOW since the 510(k) programme began in 1976, 8 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253386 | DVT Garment | Vistar Medical Supplies Co., Ltd. | |
| K250242 | Compression Therapy Device (LGT-2202DVT) | Guangzhou Longest Medical Technology Co., Ltd. | |
| K254267 | NanoPress 760A-BT (760A-BT) | Mego Afek , Ltd. | |
| K250974 | Bio Arterial Deluxe (IC-BAP-DX) | Bio Compression Systems, Inc. | |
| K250190 | Sequential Compression System (SCD600) | Shenzhen Comen Medical Instruments Co.,Ltd | |
| K251466 | VenAir, Sequential Compression System (9P-089000); VenAir, Sequential Compression System (PM01D01 / Calf garment (S)); VenAir, Sequential Compression System (PM01E01 / Calf garment (M)); VenAir, Sequential Compression System (PM01F01 / Calf garment (L)); VenAir, Sequential Compression System (PM01G01 / Thigh garment (S)); VenAir, Sequential Compression System (PM01H01 / Thigh garment (M)); VenAir, Sequential Compression System (PM01I01 / Thigh garment (L)); VenAir, Sequential Compr | Wellell, Inc. | |
| K251446 | PlasmaFlow X Compression Sleeve Device (XPF0001) | Manamed, LLC | |
| K251086 | PnueAira (PNCU-01) | Biotab, LLC | |
| K250817 | Coretech Compression System (Coretech RHB3003) | Vive Health, LLC | |
| K241096 | Venera 608 Deep Vein Thrombosis (DVT) Prevention System | Suzhou Minhua Medical Apparatus Supplies Co., Ltd. |
How long does FDA review take for JOW?
The median FDA review time for JOW is 126 days, measured across the 351 most recent decisions with both a received date and a decision date.
Review time here is decision date minus date received, as published by FDA. It is elapsed calendar time, not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Are there recalls in JOW?
openFDA lists 32 recall records against product code JOW. A recall record covers one firm's corrective action and may span many device lots.
Z-1917-2025CompletedCardinal Health 200, LLC
Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy.
Z-1918-2025CompletedCardinal Health 200, LLC
Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy.
Z-1919-2025CompletedCardinal Health 200, LLC
Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy.
Z-1612-2023Open, ClassifiedStryker Sustainability Solutions
Through complaint surveillance, it was identified that reprocessed Deep vein thrombosis (DVT) Compression Sleeves may be mislabeled and/or mispackaged.
Z-2324-2021Open, ClassifiedOrtho8, Inc.
CIRCUL8 LUXE DVT PREVENTION DEVICE is marketed without FDA clearance
Showing the 5 most recently initiated of 32. Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Status is FDA's own wording; a terminated recall is a closed one, and the total spans the code's whole history, not just what is open today.
Source: openFDA device/recall · retrieved
How many adverse events are reported for JOW?
MAUDE holds 110 adverse-event reports naming product code JOW, 23 of them received in the last 12 months.
MAUDE reports are submitted by manufacturers, importers, user facilities and the public. They are unverified, and a report is not proof that the device caused the event.
Source: openFDA device/event · retrieved
Is adverse-event reporting in JOW unusual?
JOW does not yet have twelve months of adverse-event history in our data, so there is no expected range to compare against. That is a gap in what we hold, not a statement about the device.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 2 | Insufficient history | No expected range — too little history | |
| 11 | Insufficient history | No expected range — too little history | |
| 11 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 9 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 6 | Insufficient history | No expected range — too little history | |
| 7 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 5 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 5 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 5 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 5 | Insufficient history | No expected range — too little history |
28 months do not have a full, unbroken year of history before them, so no expected range is shown for those. Insufficient history is reported as insufficient rather than as zero: an empty baseline would turn a gap in our data into a spike.
Who has entered JOW in the last year?
5 companies filed in JOW for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| Vistar Medical Supplies Co., Ltd. | K253386 | |
| Guangzhou Longest Medical Technology Co., Ltd. | K250242 | |
| SHENZHEN COMEN MEDICAL INSTRUMENTS CO., LTD. | K250190 | |
| Wellell, Inc. | K251466 | |
| Biotab, LLC | K251086 |
"First time" means their first clearance in this product code, not their first ever — an established manufacturer entering a new category is exactly the movement worth knowing about.
Source: openFDA device/510k · retrieved
What are the predicate devices in JOW?
FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet.
A predicate chain matters because a device inherits the safety history of what it was compared to. FDA publishes the chain only inside each 510(k) summary PDF, never as data — so where we have edges, they are read from those documents, and where we do not, we say so instead of showing an empty list.
Who files 510(k)s in JOW?
Across the 351 most recent decisions, these applicants filed most often in JOW.
| Applicant | Recent clearances |
|---|---|
| Bio Compression Systems, Inc. | 11 |
| Mego Afek AC , Ltd. | 11 |
| Hygia Health Services, Inc. | 9 |
| Medical Compression Systems (Dbn) , Ltd. | 9 |
| Aircast, Inc. | 7 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
The same makers, after name resolution
One company in JOW files under more than one spelling. Resolving them to one identity — across all six datasets, not just this one — is what makes a joined count possible at all.
| Company | Clearances | FDA spellings merged |
|---|---|---|
| Alliance Medical Corp. | 8 | 2 |
Merges are measured against a hand-labelled sample and held above 98% precision; pairs the matcher is unsure of are queued for a person rather than merged. See DeviceSignal.
Source: openFDA device/510k · retrieved
Watch JOW
Get an email the morning anything changes in JOW — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
Related product codes in Cardiovascular
Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.