FDA product code · Cardiovascular
DQXWire, Guide, Catheter
Product code DQX covers Wire, Guide, Catheter, a Class II device regulated under 21 CFR 870.1330. FDA has cleared 766 devices in this code, 13 of them in the last 12 months. Median review time across the 766 most recent decisions is 89 days. openFDA lists 257 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 870.1330
- Review panel
- Cardiovascular
- Clearances
- 766
What is happening in DQX right now?
DQX (Wire, Guide, Catheter) has four findings, most consequential first. 5 recalls opened in the last 12 months and not yet terminated (Class I, Class II) (Z-2517-2026, Z-2397-2026, Z-1775-2026, Z-1776-2026, Z-1777-2026). 4 first-time filers in the last 12 months, including Sp Medical A/S and Solo Pace, Inc (K253667, K252674, K250203, K251181). Clearances are running 70% slower — a median 151 days over the last 12 months against 89 days all-time (elapsed calendar days, not FDA review days) (DQX:review_time:12m). The code is crowded, scoring 95 of 100 — 195 companies hold a clearance here and 13 arrived in the last 12 months (DQX:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| Recall | Class I recall | Z-2517-2026, Z-2397-2026, Z-1775-2026, Z-1776-2026, Z-1777-2026 |
| New entrant | Worth knowing | K253667, K252674, K250203, K251181 |
| Review time | Context | DQX:review_time:12m |
| Crowding | Context | DQX: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 DQX?
FDA has cleared 766 devices under product code DQX since the 510(k) programme began in 1976, 13 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253667 | Accoat Guide Wire | Sp Medical A/S | |
| K261640 | Merit MAK Nitinol/Gold-Tungsten Guide Wire | Merit Medical Ireland , Ltd. | |
| K254137 | InQwire Amplatz Guide Wire | Merit Medical Ireland, Ltd. | |
| K260544 | FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40; FMD Peripheral Guide Wire F-18 Flex SP; FMD Peripheral Guide Wire F-18 DP 25; FMD Peripheral Guide Wire F-18 Tapered 40 | FMD Co., Ltd. | |
| K253746 | Enroute 0.014'' Transcarotid Guidewire | Lake Region Medical | |
| K253262 | EmeryGlide (EG18008901) | Nano4imaging GmbH | |
| K253847 | Splashwire Hydrophilic Guide Wire (MSWSTD35150J3) | Merit Medical Ireland, Ltd. | |
| K251385 | InQwire Super Stiff Guide Wire (IQSS32180J3); InQwire Super Stiff Guide Wire (IQSS35F260S); InQwire Super Stiff Guide Wire (IQSS35F150S); InQwire Super Stiff Guide Wire (IQSS35F100S); InQwire Super Stiff Guide Wire (IQSS35F80S); InQwire Super Stiff Guide Wire (IQSS35F180S) | Merit Medical Ireland, Ltd. | |
| K252674 | Solo Pace Fusion System (SOLOFUSE1) | Solo Pace, Inc. | |
| K251596 | Lunderquist Extra Stiff Wire Guide | William Cook Europe Aps |
How long does FDA review take for DQX?
The median FDA review time for DQX is 89 days, measured across the 766 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 DQX?
openFDA lists 257 recall records against product code DQX. A recall record covers one firm's corrective action and may span many device lots.
Z-2517-2026Open, ClassifiedMerit Medical Systems, Inc.
Due to unsealed portions of pouches.
Z-2397-2026Open, ClassifiedArrow International, Inc., Division of Teleflex Medical Inc.
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Z-1775-2026Open, ClassifiedCook Incorporated
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Z-1776-2026Open, ClassifiedCook Incorporated
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Z-1777-2026Open, ClassifiedCook Incorporated
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Showing the 5 most recently initiated of 257. 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 DQX?
MAUDE holds 6,388 adverse-event reports naming product code DQX, 1,423 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 DQX unusual?
Every month with enough history behind it falls inside DQX's own expected range. Nothing here is unusual for this code.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 105 | Insufficient history | No expected range — too little history | |
| 149 | Insufficient history | No expected range — too little history | |
| 210 | Insufficient history | No expected range — too little history | |
| 122 | Insufficient history | No expected range — too little history | |
| 144 | Insufficient history | No expected range — too little history | |
| 149 | Insufficient history | No expected range — too little history | |
| 134 | Insufficient history | No expected range — too little history | |
| 327 | Insufficient history | No expected range — too little history | |
| 118 | Insufficient history | No expected range — too little history | |
| 177 | Insufficient history | No expected range — too little history | |
| 194 | Insufficient history | No expected range — too little history | |
| 164 | Insufficient history | No expected range — too little history | |
| 152 | Insufficient history | No expected range — too little history | |
| 266 | Insufficient history | No expected range — too little history | |
| 131 | Insufficient history | No expected range — too little history | |
| 166 | Insufficient history | No expected range — too little history | |
| 212 | Insufficient history | No expected range — too little history | |
| 150 | Insufficient history | No expected range — too little history | |
| 233 | Insufficient history | No expected range — too little history | |
| 166 | Insufficient history | No expected range — too little history | |
| 199 | Insufficient history | No expected range — too little history | |
| 137 | 108–234 | Within expected (108–234) | |
| 139 | 82–198 | Within expected (82–198) | |
| 146 | 92–220 | Within expected (92–220) | |
| 219 | 91–225 | Within expected (91–225) | |
| 170 | 99–235 | Within expected (99–235) | |
| 171 | 120–225 | Within expected (120–225) | |
| 197 | 192–349 | Within expected (192–349) | |
| 169 | 125–252 | Within expected (125–252) | |
| 201 | 125–258 | Within expected (125–258) | |
| 175 | 131–257 | Within expected (131–257) | |
| 217 | 116–222 | Within expected (116–222) | |
| 180 | 140–267 | Within expected (140–267) | |
| 159 | 152–300 | Within expected (152–300) | |
| 167 | 106–243 | Within expected (106–243) | |
| 197 | 112–266 | Within expected (112–266) |
21 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. Method: ewma_alpha_0.3_sd_2 corpus_adjusted. Counts are divided by the corpus-wide volume for that month before comparison, so a rise across all of MAUDE is not reported as a rise in DQX.
Who has entered DQX in the last year?
4 companies filed in DQX for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| Sp Medical A/S | K253667 | |
| Solo Pace, Inc. | K252674 | |
| SUREAX MEDICAL, CORPORATION | K250203 | |
| Merit Medical Ireland , Ltd. | K251181 |
"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 DQX?
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 DQX?
Across the 766 most recent decisions, these applicants filed most often in DQX.
| Applicant | Recent clearances |
|---|---|
| Asahi Intecc Co., Ltd. | 47 |
| Advanced Cardiovascular Systems, Inc. | 45 |
| Lake Region Mfg., Inc. | 31 |
| Scimed Life Systems, Inc. | 30 |
| Cordis Corp. | 25 |
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 DQX 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 |
|---|---|---|
| Boston Scientific Corporation | 34 | 4 |
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 DQX
Get an email the morning anything changes in DQX — 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.