FDA product code · Cardiovascular
DTZOxygenator, Cardiopulmonary Bypass
Product code DTZ covers Oxygenator, Cardiopulmonary Bypass, a Class II device regulated under 21 CFR 870.4350. FDA has cleared 254 devices in this code, 4 of them in the last 12 months. Median review time across the 254 most recent decisions is 88 days. openFDA lists 107 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 870.4350
- Review panel
- Cardiovascular
- Clearances
- 254
What is happening in DTZ right now?
DTZ (Oxygenator, Cardiopulmonary Bypass) has three findings, most consequential first. 1 recall opened in the last 12 months and not yet terminated (Class II) (Z-0487-2026). 2 first-time filers in the last 12 months, Lifemotion Medical Technology Co., Ltd. and Spectrum Medical S.R.L (K253838, K240934). The code is crowded, scoring 69 of 100 — 59 companies hold a clearance here and 4 arrived in the last 12 months (DTZ:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| Recall | Class II recall | Z-0487-2026 |
| New entrant | Worth knowing | K253838, K240934 |
| Crowding | Context | DTZ: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 DTZ?
FDA has cleared 254 devices under product code DTZ since the 510(k) programme began in 1976, 4 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253838 | Lifemotion Disposable Membrane Oxygenator | Lifemotion Medical Technology Co., Ltd. | |
| K240934 | Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); Quantum Perfusion Blood Oxygenator ECC VT200-E3 (VT200-E3); Quantum Perfusion Blood Oxygenator VT75- E3 (VT75- E3); | Spectrum Medical S.R.L. | |
| K250821 | Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR and Horizon CVR) (US5300); A.L. One AF Plus OXYGENATOR (US5204); Horizon CVR (US5073) | Eurosets S.R.L | |
| K242503 | Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232) | Eurosets S.R.L | |
| K231982 | Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2 | Qura S.R.L | |
| K240666 | Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface (BB811); Affinity Fusion Oxygenator with Integrated Arterial Filter and Cardiotomy/Venous Reservoir with Balance Biosurface (BB841); Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface NON STERILE (BB811-NS) | Medtronic Perfusion Systems | |
| K241352 | Affinity NT Oxygenator and Uncoated Cardiotomy/ Venous Reservoir (541); Affinity NT Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir (541B) | Medtronic, Inc. | |
| K231652 | D100 KIDS; D101 KIDS | Sorin Group Italia S.R.L. | |
| K231773 | Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT75-C1U, Quantum Perfusion Blood Oxygenator with Integrated AF VT75-C2U, Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT200-C1U, Quantum Perfusion Blood Oxygenator with Integrated AF VT200-C2U, Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT160-C1U | Qura S.R.L | |
| K231414 | CMO8 Adult PMP Oxygenator with Tubing Pack (Model: CME40009) | Chalice Medical , Ltd. |
How long does FDA review take for DTZ?
The median FDA review time for DTZ is 88 days, measured across the 254 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 DTZ?
openFDA lists 107 recall records against product code DTZ. A recall record covers one firm's corrective action and may span many device lots.
Z-0487-2026Open, ClassifiedMedtronic Perfusion Systems
Medtronic identified an Affinity NT Oxygenator unit with decreased CO2 gas transfer rates that did not meet performance requirements.
Z-1076-2024Open, ClassifiedMaquet Medical Systems, Usa
The Emergency Priming Line, a component of the HLS Set, may have a compromised sterile barrier due to nonconformities at the bag seal. This issue may result in inflammation, sepsis, or infection.
Z-1077-2024Open, ClassifiedMaquet Medical Systems, Usa
The Emergency Priming Line, a component of the HLS Set, may have a compromised sterile barrier due to nonconformities at the bag seal. This issue may result in inflammation, sepsis, or infection.
Z-1634-2023Open, ClassifiedMaquet Medical Systems, Usa
1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's sterile pouch. 2. Product packaging may exhibit holes, cracks, dents, and crushed areas. Both issues may compromise the sterile barrier of the packaging, and exposure to non-sterile product may result in inflammation, infection, sepsis, and ischemia.
Z-1635-2023Open, ClassifiedMaquet Medical Systems, Usa
1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory s sterile pouch. 2. Product packaging may exhibit holes, cracks, dents, and crushed areas. Both issues may compromise the sterile barrier of the packaging, and exposure to non-sterile product may result in inflammation, infection, sepsis, and ischemia.
Showing the 5 most recently initiated of 107. 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 DTZ?
MAUDE holds 2,503 adverse-event reports naming product code DTZ, 892 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 DTZ unusual?
2 months sit above DTZ's own expected range: 1 February 2025, 1 November 2025.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 67 | Insufficient history | No expected range — too little history | |
| 50 | Insufficient history | No expected range — too little history | |
| 49 | Insufficient history | No expected range — too little history | |
| 64 | Insufficient history | No expected range — too little history | |
| 67 | Insufficient history | No expected range — too little history | |
| 148 | Insufficient history | No expected range — too little history | |
| 50 | Insufficient history | No expected range — too little history | |
| 62 | Insufficient history | No expected range — too little history | |
| 48 | Insufficient history | No expected range — too little history | |
| 46 | Insufficient history | No expected range — too little history | |
| 47 | Insufficient history | No expected range — too little history | |
| 41 | Insufficient history | No expected range — too little history | |
| 55 | Insufficient history | No expected range — too little history | |
| 53 | Insufficient history | No expected range — too little history | |
| 34 | Insufficient history | No expected range — too little history | |
| 45 | Insufficient history | No expected range — too little history | |
| 29 | Insufficient history | No expected range — too little history | |
| 31 | Insufficient history | No expected range — too little history | |
| 58 | Insufficient history | No expected range — too little history | |
| 56 | Insufficient history | No expected range — too little history | |
| 40 | Insufficient history | No expected range — too little history | |
| 42 | 22–60 | Within expected (22–60) | |
| 53 | 20–52 | Above expected (20–52) | |
| 61 | 25–67 | Within expected (25–67) | |
| 75 | 28–77 | Within expected (28–77) | |
| 67 | 28–83 | Within expected (28–83) | |
| 56 | 29–93 | Within expected (29–93) | |
| 79 | 44–142 | Within expected (44–142) | |
| 102 | 31–103 | Within expected (31–103) | |
| 80 | 41–123 | Within expected (41–123) | |
| 106 | 46–116 | Within expected (46–116) | |
| 121 | 44–115 | Above expected (44–115) | |
| 123 | 51–153 | Within expected (51–153) | |
| 159 | 68–182 | Within expected (68–182) | |
| 101 | 65–165 | Within expected (65–165) | |
| 123 | 68–174 | Within expected (68–174) |
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 DTZ.
Who has entered DTZ in the last year?
2 companies filed in DTZ for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| Lifemotion Medical Technology Co., Ltd. | K253838 | |
| Spectrum Medical S.R.L. | K240934 |
"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 DTZ?
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 DTZ?
Across the 254 most recent decisions, these applicants filed most often in DTZ.
| Applicant | Recent clearances |
|---|---|
| Sorin Group Italia S.R.L. | 22 |
| Medtronic, Inc. | 15 |
| American Bentley | 13 |
| Maquet Cardiopulmonary, AG | 13 |
| Medtronic Vascular | 12 |
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 DTZ 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 |
|---|---|---|
| Medtronic, Inc. | 16 | 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 DTZ
Get an email the morning anything changes in DTZ — 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.