FDA product code · Cardiovascular
DXCClamp, Vascular
Product code DXC covers Clamp, Vascular, a Class II device regulated under 21 CFR 870.4450. FDA has cleared 205 devices in this code, 6 of them in the last 12 months. Median review time across the 205 most recent decisions is 94 days. openFDA lists 26 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 870.4450
- Review panel
- Cardiovascular
- Clearances
- 205
What is happening in DXC right now?
DXC (Clamp, Vascular) has four findings, most consequential first. 3 recalls opened in the last 12 months and not yet terminated (Class II) (Z-2586-2025, Z-2587-2025, Z-2588-2025). Adverse events reported in 2026-03 ran high — 84 reports against an expected 0 to 62 (DXC:MAUDE:2026-03). 3 first-time filers in the last 12 months, including TW Medical and Arc Trauma, LLC (K254060, K243627, K253070). The code is crowded, scoring 83 of 100 — 123 companies hold a clearance here and 6 arrived in the last 12 months (DXC:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| Recall | Class II recall | Z-2586-2025, Z-2587-2025, Z-2588-2025 |
| Adverse-event spike | Serious | DXC:MAUDE:2026-03 |
| New entrant | Worth knowing | K254060, K243627, K253070 |
| Crowding | Context | DXC: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 DXC?
FDA has cleared 205 devices under product code DXC 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 |
|---|---|---|---|
| K262086 | PreludeSYNC Radial Compression Device | Merit Medical Systems, Inc. | |
| K260105 | Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts | Edwards Lifesciences | |
| K252772 | Arc Adjustable Radial Cuff Compression Device | Tz Medical, Inc. | |
| K254060 | Life Saving Tourniquet | TW Medical | |
| K243627 | Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC) | Arc Trauma, LLC | |
| K253070 | Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRADBANDL) | Medline Industries, LP | |
| K232577 | Radial Compression Device | Ningbo Dizegens Medical Science Co.,Ltd | |
| K230281 | PICOCLAMP | Kono Seisakusho Co., Ltd. | |
| K221661 | Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S) | Compression Works, Inc. | |
| K230248 | VIOLA | Vascular Graft Solutions, Ltd. |
How long does FDA review take for DXC?
The median FDA review time for DXC is 94 days, measured across the 205 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 DXC?
openFDA lists 26 recall records against product code DXC. A recall record covers one firm's corrective action and may span many device lots.
Z-2586-2025Open, ClassifiedMaquet Cardiovascular, LLC
Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the Heartstring Seal to deploy into the aortotomy, and failure of the deployed Heartstring Seal to provide adequate hemostasis.
Z-2587-2025Open, ClassifiedMaquet Cardiovascular, LLC
Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the Heartstring Seal to deploy into the aortotomy, and failure of the deployed Heartstring Seal to provide adequate hemostasis.
Z-2588-2025Open, ClassifiedMaquet Cardiovascular, LLC
Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the Heartstring Seal to deploy into the aortotomy, and failure of the deployed Heartstring Seal to provide adequate hemostasis.
Z-2637-2025Open, ClassifiedNorth American Rescue LLC.
Device used for unilateral or bilateral occlusion of blood flow to the lower limbs has a potential manufacturing defect that may compromise the structural integrity of the device and device performance during use.
Z-1522-2024Open, ClassifiedBaxter Healthcare Corporation
The Surgical Tools and Cardiovascular Specialty marketing brochures distributed for Flo-Rester Disposable Internal Vessel Occluder, Flo-Thru Intraluminal Shunt, and Vascular Probe Intravascular Probe contain inaccurate content that does not align with the products Instructions for Use (IFU).
Showing the 5 most recently initiated of 26. 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 DXC?
MAUDE holds 1,511 adverse-event reports naming product code DXC, 270 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 DXC unusual?
2 months sit above DXC's own expected range: 1 May 2025, 1 March 2026.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 20 | Insufficient history | No expected range — too little history | |
| 37 | Insufficient history | No expected range — too little history | |
| 40 | Insufficient history | No expected range — too little history | |
| 30 | Insufficient history | No expected range — too little history | |
| 102 | Insufficient history | No expected range — too little history | |
| 194 | Insufficient history | No expected range — too little history | |
| 73 | Insufficient history | No expected range — too little history | |
| 44 | Insufficient history | No expected range — too little history | |
| 26 | Insufficient history | No expected range — too little history | |
| 24 | Insufficient history | No expected range — too little history | |
| 21 | Insufficient history | No expected range — too little history | |
| 37 | Insufficient history | No expected range — too little history | |
| 28 | Insufficient history | No expected range — too little history | |
| 45 | Insufficient history | No expected range — too little history | |
| 40 | Insufficient history | No expected range — too little history | |
| 41 | Insufficient history | No expected range — too little history | |
| 17 | Insufficient history | No expected range — too little history | |
| 28 | Insufficient history | No expected range — too little history | |
| 32 | Insufficient history | No expected range — too little history | |
| 33 | Insufficient history | No expected range — too little history | |
| 29 | Insufficient history | No expected range — too little history | |
| 18 | 11–45 | Within expected (11–45) | |
| 34 | 6–37 | Within expected (6–37) | |
| 29 | 11–46 | Within expected (11–46) | |
| 29 | 12–47 | Within expected (12–47) | |
| 47 | 11–44 | Above expected (11–44) | |
| 46 | 16–54 | Within expected (16–54) | |
| 76 | 28–92 | Within expected (28–92) | |
| 28 | 22–76 | Within expected (22–76) | |
| 33 | 19–71 | Within expected (19–71) | |
| 27 | 15–67 | Within expected (15–67) | |
| 22 | 9–57 | Within expected (9–57) | |
| 45 | 5–61 | Within expected (5–61) | |
| 19 | 10–74 | Within expected (10–74) | |
| 18 | 2–59 | Within expected (2–59) | |
| 84 | 0–62 | Above expected (0–62) |
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 DXC.
Who has entered DXC in the last year?
3 companies filed in DXC for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| TW Medical | K254060 | |
| Arc Trauma, LLC | K243627 | |
| Medline Industries, LP | K253070 |
"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 DXC?
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 DXC?
Across the 205 most recent decisions, these applicants filed most often in DXC.
| Applicant | Recent clearances |
|---|---|
| Radi Medical Systems AB | 8 |
| Cardiva Medical, Inc. | 7 |
| Advanced Vascular Dynamics | 6 |
| Novare Surgical Systems, Inc. | 6 |
| Applied Vascular Devices, Inc. | 5 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
Source: openFDA device/510k · retrieved
Watch DXC
Get an email the morning anything changes in DXC — 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.