FDA product code · Cardiovascular
DXQBlood Pressure Cuff
Product code DXQ covers Blood Pressure Cuff, a Class II device regulated under 21 CFR 870.1120. FDA has cleared 199 devices in this code, 6 of them in the last 12 months. Median review time across the 199 most recent decisions is 81 days. openFDA lists 27 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 870.1120
- Review panel
- Cardiovascular
- Clearances
- 199
What is happening in DXQ right now?
DXQ (Blood Pressure Cuff) has three findings, most consequential first. 1 recall opened in the last 12 months and not yet terminated (Class II) (Z-0847-2026). 4 first-time filers in the last 12 months, including Nihon Kohden Corporation and Shenzhen Best Electronics Co., Ltd (K260747, K253089, K251745, K250765). The code is crowded, scoring 86 of 100 — 136 companies hold a clearance here and 6 arrived in the last 12 months (DXQ:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| Recall | Class II recall | Z-0847-2026 |
| New entrant | Worth knowing | K260747, K253089, K251745, K250765 |
| Crowding | Context | DXQ: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.
What does product code DXQ cover?
DXQ is FDA's product code for Blood Pressure Cuff, a Class II device regulated under 21 CFR 870.1120.
A blood pressure cuff is a device that has an inflatable bladder in an elastic sleeve (cuff) with a mechanism for inflating the bladder. The cuff is used to determine a subject's blood pressure.
Source: openFDA device/classification · record DXQ · retrieved
How many devices has FDA cleared in DXQ?
FDA has cleared 199 devices under product code DXQ since the 510(k) programme began in 1976, 6 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254287 | Medline Reusable Blood Pressure Cuff | Medline Industries, LP | |
| K260747 | YP-710T Series NIBP Cuff;YP-840T Series Disposable Cuff | Nihon Kohden Corporation | |
| K253089 | NIBP Cuff (BCS-112, BCS-212, BCS-312, BCS-412, BCS-512, BCS-612, BCS-712, BCS-122, BCS-222, BCS-322, BCS-422, BCS-522, BCS-622, BCS-722, BCD-112, BCD-212, BCD-312, BCD-412, BCD-512, BCD-612, BCD-712, BCD-122, BCD-222, BCD-322, BCD-422, BCD-522, BCD-622, BCD-722) | Shenzhen Best Electronics Co., Ltd. | |
| K253964 | Disposable Neonatal NIBP Cuff (U1681S-C51N) | Unimed Medical Supplies, Inc. | |
| K251745 | Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs) | Baxter Healthcare Corporation | |
| K250765 | AViTA Arm Type Blood Pressure Monitor Cuff | Avita Corporation | |
| K251045 | Disposable Neonatal NIBP Cuff (U1682S-C51N); Disposable Neonatal NIBP Cuff (U1683S-C51N); Disposable Neonatal NIBP Cuff (U1684S-C51N); Disposable Neonatal NIBP Cuff (U1685S-C51N) | Unimed Medical Supplies, Inc. | |
| K242623 | Disposable Blood Pressure cuff; Reusable Blood Pressure cuff | Shenzhen Medke Technology Co., Ltd. | |
| K240165 | Aneroid Sphygmomanometer with Stethoscope; Aneroid Sphygmomanometer | Wenzhou Longwan Medical Device Factory | |
| K233276 | Reusable Blood Pressure Cuff | Suzhou Minhua Medical Apparatus Supplies Co., Ltd. |
How long does FDA review take for DXQ?
The median FDA review time for DXQ is 81 days, measured across the 199 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 DXQ?
openFDA lists 27 recall records against product code DXQ. A recall record covers one firm's corrective action and may span many device lots.
Z-0847-2026Open, ClassifiedBaxter Healthcare Corporation
Replacement bladder kit for the Welch Allyn two-piece reusable blood pressure cuff may contain a Large Adult size bladder rather than a Thigh size bladder in the replacement kits.
Z-1562-2025Open, ClassifiedBaxter Healthcare Corporation
Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
Z-1564-2025Open, ClassifiedBaxter Healthcare Corporation
Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
Z-1566-2025Open, ClassifiedBaxter Healthcare Corporation
Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
Z-1567-2025Open, ClassifiedBaxter Healthcare Corporation
Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
Showing the 5 most recently initiated of 27. 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 DXQ?
MAUDE holds 44 adverse-event reports naming product code DXQ, 17 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 DXQ unusual?
DXQ 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 | |
| 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 | |
| 2 | Insufficient history | No expected range — too little history | |
| 1 | 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 | |
| 1 | Insufficient history | No expected range — too little history | |
| 2 | 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 | |
| 1 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 6 | 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 | |
| 2 | Insufficient history | No expected range — too little history |
20 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 DXQ in the last year?
4 companies filed in DXQ for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| Nihon Kohden Corporation | K260747 | |
| Shenzhen Best Electronics Co., Ltd. | K253089 | |
| Baxter Healthcare Corporation | K251745 | |
| Avita Corporation | K250765 |
"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 DXQ?
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 DXQ?
Across the 199 most recent decisions, these applicants filed most often in DXQ.
| Applicant | Recent clearances |
|---|---|
| Rudolf Riester GmbH & Co. KG | 8 |
| Conphar, Inc. | 6 |
| Abco Dealers, Inc. | 5 |
| Pymah Corp. | 5 |
| Ethox Corp. | 4 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
Source: openFDA device/510k · retrieved
Watch DXQ
Get an email the morning anything changes in DXQ — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
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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.