FDA product code · Cardiovascular
DXTInjector And Syringe, Angiographic
Product code DXT covers Injector And Syringe, Angiographic, a Class II device regulated under 21 CFR 870.1650. FDA has cleared 210 devices in this code, 7 of them in the last 12 months. Median review time across the 210 most recent decisions is 98 days. openFDA lists 69 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 870.1650
- Review panel
- Cardiovascular
- Clearances
- 210
What is happening in DXT right now?
DXT (Injector And Syringe, Angiographic) has three findings, most consequential first. 5 recalls opened in the last 12 months and not yet terminated (Class I, Class II) (Z-2296-2026, Z-1712-2026, Z-1713-2026, Z-1830-2026, Z-1831-2026). 3 first-time filers in the last 12 months, including Fortis Biosolutions Company Limited and Shenzhen Maiwei Biotech Co., Ltd (K252652, K253048, K251788). The code is crowded, scoring 80 of 100 — 86 companies hold a clearance here and 7 arrived in the last 12 months (DXT:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| Recall | Class I recall | Z-2296-2026, Z-1712-2026, Z-1713-2026, Z-1830-2026, Z-1831-2026 |
| New entrant | Worth knowing | K252652, K253048, K251788 |
| Crowding | Context | DXT: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 DXT?
FDA has cleared 210 devices under product code DXT since the 510(k) programme began in 1976, 7 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252652 | Disposable Syringes with Accessories for Power Injectors (900103T); Disposable Syringes with Accessories for Power Injectors (900103H); Disposable Syringes with Accessories for Power Injectors (801800H); Disposable Syringes with Accessories for Power Injectors (800099T); Disposable Syringes with Accessories for Power Injectors (800099H); Disposable Syringes with Accessories for Power Injectors (800096T); Disposable Syringes with Accessories for Power Injectors (800096H); Disposable Syr | Fortis Biosolutions Company Limited | |
| K252653 | ACIST Pro Diagnostic System (019304); Processing Unit Bed Mount; AngioTouch Module; ACIST Pro Cart; Single Transducer Cable; Triple Transducer Cable | Acist Medical Systems, Inc. | |
| K252638 | VeraPro S100 Multi-Use Syringe (018808); VeraPro S100 LV1 Low Viscosity Single-Use Syringe (018811); VeraPro AMT Auto-Manifold and Transducer (018814); VeraPro AngioTouch FLX165 Hand Controller Kit (018806); VeraPro AngioTouch HiFi165 Hand Controller Kit (018804) | Acist Medical Systems, Inc. | |
| K253048 | High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer Tube | Shenzhen Maiwei Biotech Co., Ltd. | |
| K251788 | Extension tube | Zhuhai DR Medical Instruments Co., Ltd. | |
| K252891 | MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD ISI2 Module (ISI2) | Bayer Medical Care, Inc. | |
| K244038 | High Pressure Tubing | Shandong Int Medical Instruments Co., Ltd. | |
| K242143 | Angiography Injector | Shandong Int Medical Instruments Co., Ltd. | |
| K242212 | Disposable Syringe (Kit); Nemoto Disposable Syringe (Kit) | Nemoto Kyorindo Co., Ltd. | |
| K241109 | Single-use Sterile High-pressure Angiographic Syringes and Accessories | Shenzhen Boon Medical Supply Co., Ltd. |
How long does FDA review take for DXT?
The median FDA review time for DXT is 98 days, measured across the 210 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 DXT?
openFDA lists 69 recall records against product code DXT. A recall record covers one firm's corrective action and may span many device lots.
Z-2296-2026Open, ClassifiedBayer Medical Care, Inc.
Supplier changes resulted in a fit issue with the Contrast Flow Control Valve (CFCV) interface on the Avanta Injector System. Multiple customer reports indicate that the stopcock cannot be reliably engaged with the CFCV snap interface. In instances where engagement is achieved through applied force, the connection is unstable, and the stopcock may disengage before or during contrast injection, leading to procedure interruption.
Z-1712-2026Open, ClassifiedMedline Industries, LP
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Z-1713-2026Open, ClassifiedMedline Industries, LP
Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
Z-1830-2026Open, ClassifiedMedline Industries, LP
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Z-1831-2026Open, ClassifiedMedline Industries, LP
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Showing the 5 most recently initiated of 69. 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 DXT?
MAUDE holds 377 adverse-event reports naming product code DXT, 119 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 DXT unusual?
2 months sit above DXT's own expected range: 1 March 2025, 1 February 2026.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 6 | 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 | |
| 9 | Insufficient history | No expected range — too little history | |
| 12 | Insufficient history | No expected range — too little history | |
| 5 | Insufficient history | No expected range — too little history | |
| 6 | Insufficient history | No expected range — too little history | |
| 6 | Insufficient history | No expected range — too little history | |
| 25 | Insufficient history | No expected range — too little history | |
| 17 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history | |
| 10 | Insufficient history | No expected range — too little history | |
| 8 | Insufficient history | No expected range — too little history | |
| 9 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history | |
| 7 | Insufficient history | No expected range — too little history | |
| 14 | Insufficient history | No expected range — too little history | |
| 9 | Insufficient history | No expected range — too little history | |
| 8 | Insufficient history | No expected range — too little history | |
| 8 | Insufficient history | No expected range — too little history | |
| 20 | Insufficient history | No expected range — too little history | |
| 9 | 2–20 | Within expected (2–20) | |
| 6 | 2–15 | Within expected (2–15) | |
| 16 | 2–16 | Above expected (2–16) | |
| 4 | 3–20 | Within expected (3–20) | |
| 6 | 0–17 | Within expected (0–17) | |
| 7 | 0–17 | Within expected (0–17) | |
| 6 | 0–25 | Within expected (0–25) | |
| 10 | 0–18 | Within expected (0–18) | |
| 9 | 0–20 | Within expected (0–20) | |
| 7 | 0–19 | Within expected (0–19) | |
| 5 | 0–17 | Within expected (0–17) | |
| 10 | 0–19 | Within expected (0–19) | |
| 14 | 0–19 | Within expected (0–19) | |
| 39 | 1–17 | Above expected (1–17) | |
| 29 | 0–41 | Within expected (0–41) |
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 DXT.
Who has entered DXT in the last year?
3 companies filed in DXT for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| Fortis Biosolutions Company Limited | K252652 | |
| Shenzhen Maiwei Biotech Co., Ltd. | K253048 | |
| Zhuhai DR Medical Instruments Co., Ltd. | K251788 |
"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 DXT?
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 DXT?
Across the 210 most recent decisions, these applicants filed most often in DXT.
| Applicant | Recent clearances |
|---|---|
| Medrad, Inc. | 32 |
| Osprey Medical, Inc. | 14 |
| Coeur, Inc. | 10 |
| Acist Medical Systems, Inc. | 8 |
| Bayer Medical Care, 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
2 companies in DXT file 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 |
|---|---|---|
| Osprey Medical, Inc. | 15 | 2 |
| Acist Medical Systems | 12 | 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 DXT
Get an email the morning anything changes in DXT — 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.