FDA product code · Cardiovascular
DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Product code DWF covers Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass, a Class II device regulated under 21 CFR 870.4210. FDA has cleared 401 devices in this code, 7 of them in the last 12 months. Median review time across the 401 most recent decisions is 83 days. openFDA lists 560 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 870.4210
- Review panel
- Cardiovascular
- Clearances
- 401
What is happening in DWF right now?
DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass) has three findings, most consequential first. 5 recalls opened in the last 12 months and not yet terminated (Z-2806-2026, Z-2807-2026, Z-2808-2026, Z-2809-2026, Z-2810-2026). 1 first-time filer in the last 12 months, Smart Reactors (K260043). The code is crowded, scoring 76 of 100 — 117 companies hold a clearance here and 7 arrived in the last 12 months (DWF:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| Recall | Serious | Z-2806-2026, Z-2807-2026, Z-2808-2026, Z-2809-2026, Z-2810-2026 |
| New entrant | Worth knowing | K260043 |
| Crowding | Context | DWF: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 DWF?
FDA has cleared 401 devices under product code DWF 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 |
|---|---|---|---|
| K260195 | Elongated One-Piece Arterial (EOPA) 3D Arterial Cannulae | Medtronic, Inc. | |
| K250937 | Venous Return Cannulae | LivaNova USA, Inc. | |
| K260043 | Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C) | Smart Reactors | |
| K253203 | Retrograde Coronary Sinus Perfusion Cannulae | Medtronic, Inc. | |
| K253671 | Dual Stage Venous Cannulae | Sorin Group Italia S.R.L. | |
| K253998 | Clearview Intracoronary Shunts | Medtronic, Inc. | |
| K253106 | AngioVac Cannula | AngioDynamics, Inc. | |
| K250283 | RAP Femoral Venous Cannulae | LivaNova USA, Inc. | |
| K250610 | Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310) | Sorin Group Italia S.R.L. | |
| K251258 | MC2 Two-Stage Venous Cannula; MC2X Three-Stage Venous Cannula | Medtronic, Inc. |
How long does FDA review take for DWF?
The median FDA review time for DWF is 83 days, measured across the 401 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 DWF?
openFDA lists 560 recall records against product code DWF. A recall record covers one firm's corrective action and may span many device lots.
Z-2806-2026Open, ClassifiedMedtronic Perfusion Systems
Medtronic received reports of pinhole leaks in the wire-wound body of 22 Fr EOPA 3D Arterial Cannulae and EOPA Elongated One-Piece Arterial Cannulae used during cardiopulmonary bypass procedures.
Z-2807-2026Open, ClassifiedMedtronic Perfusion Systems
Medtronic received reports of pinhole leaks in the wire-wound body of 22 Fr EOPA 3D Arterial Cannulae and EOPA Elongated One-Piece Arterial Cannulae used during cardiopulmonary bypass procedures.
Z-2808-2026Open, ClassifiedMedtronic Perfusion Systems
Medtronic received reports of pinhole leaks in the wire-wound body of 22 Fr EOPA 3D Arterial Cannulae and EOPA Elongated One-Piece Arterial Cannulae used during cardiopulmonary bypass procedures.
Z-2809-2026Open, ClassifiedMedtronic Perfusion Systems
Medtronic received reports of pinhole leaks in the wire-wound body of 22 Fr EOPA 3D Arterial Cannulae and EOPA Elongated One-Piece Arterial Cannulae used during cardiopulmonary bypass procedures.
Z-2810-2026Open, ClassifiedMedtronic Perfusion Systems
Medtronic received reports of pinhole leaks in the wire-wound body of 22 Fr EOPA 3D Arterial Cannulae and EOPA Elongated One-Piece Arterial Cannulae used during cardiopulmonary bypass procedures.
Showing the 5 most recently initiated of 560. 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 DWF?
MAUDE holds 2,099 adverse-event reports naming product code DWF, 771 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 DWF unusual?
One month sits above DWF's own expected range: 1 February 2025.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 19 | Insufficient history | No expected range — too little history | |
| 24 | Insufficient history | No expected range — too little history | |
| 24 | Insufficient history | No expected range — too little history | |
| 26 | Insufficient history | No expected range — too little history | |
| 76 | Insufficient history | No expected range — too little history | |
| 67 | Insufficient history | No expected range — too little history | |
| 69 | Insufficient history | No expected range — too little history | |
| 23 | Insufficient history | No expected range — too little history | |
| 29 | Insufficient history | No expected range — too little history | |
| 20 | Insufficient history | No expected range — too little history | |
| 24 | Insufficient history | No expected range — too little history | |
| 20 | Insufficient history | No expected range — too little history | |
| 33 | Insufficient history | No expected range — too little history | |
| 33 | Insufficient history | No expected range — too little history | |
| 23 | Insufficient history | No expected range — too little history | |
| 46 | Insufficient history | No expected range — too little history | |
| 33 | Insufficient history | No expected range — too little history | |
| 32 | Insufficient history | No expected range — too little history | |
| 48 | Insufficient history | No expected range — too little history | |
| 39 | Insufficient history | No expected range — too little history | |
| 50 | Insufficient history | No expected range — too little history | |
| 26 | 21–54 | Within expected (21–54) | |
| 191 | 16–43 | Above expected (16–43) | |
| 65 | 0–193 | Within expected (0–193) | |
| 83 | 0–192 | Within expected (0–192) | |
| 59 | 0–181 | Within expected (0–181) | |
| 67 | 0–180 | Within expected (0–180) | |
| 52 | 0–277 | Within expected (0–277) | |
| 60 | 0–195 | Within expected (0–195) | |
| 151 | 0–200 | Within expected (0–200) | |
| 65 | 0–226 | Within expected (0–226) | |
| 84 | 0–194 | Within expected (0–194) | |
| 81 | 0–214 | Within expected (0–214) | |
| 148 | 0–242 | Within expected (0–242) | |
| 116 | 0–215 | Within expected (0–215) | |
| 76 | 47–177 | Within expected (47–177) |
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 DWF.
Who has entered DWF in the last year?
One company filed in DWF for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| Smart Reactors | K260043 |
"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 DWF?
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 DWF?
Across the 401 most recent decisions, these applicants filed most often in DWF.
| Applicant | Recent clearances |
|---|---|
| Medtronic, Inc. | 31 |
| Dlp, Inc. | 22 |
| 3M Health Care, Sarns | 21 |
| Shiley, Inc. | 21 |
| Edwards Lifesciences, LLC | 18 |
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 DWF 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 |
|---|---|---|
| Edwards Lifesciences, LLC | 19 | 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 DWF
Get an email the morning anything changes in DWF — 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.