FDA product code · Anesthesiology
CACApparatus, Autotransfusion
Product code CAC covers Apparatus, Autotransfusion, a Class II device regulated under 21 CFR 868.5830. FDA has cleared 195 devices in this code. Median review time across the 195 most recent decisions is 101 days. openFDA lists 89 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 868.5830
- Review panel
- Anesthesiology
- Clearances
- 195
What is happening in CAC right now?
CAC (Apparatus, Autotransfusion): nothing changed in the six FDA sources we watch.
Checked predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Nothing changed, so there is nothing here — which is the point. We only write when something did.
How many devices has FDA cleared in CAC?
FDA has cleared 195 devices under product code CAC since the 510(k) programme began in 1976.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K241236 | XTRA Collection sets; XTRA Sequestration set X | Sorin Group Italia S.R.L. | |
| K240426 | Aventus Clot Management System | Inquis Medical | |
| K240584 | XTRA Autotransfusion System (with XTRA Bowl sets) | Sorin Group Italia S.R.L. | |
| K231782 | FlowSaver Blood Return System (80-101) | Inari Medical, Inc. | |
| K221483 | FlowSaver Blood Return System | Inari Medical, Inc. | |
| K221722 | Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US) | Haemonetics Corporation | |
| K201305 | Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction Water Seal Chest Drain, Express Dry Seal Chest Drain | Atrium Medical Corporation | |
| K210862 | Hemafuse System | Sisu Global Health | |
| K210176 | FlowSaver Blood Filter | Inari Medical | |
| K210089 | CATSmart, Automated Blood Processing Autotransfusion System | Fresenius Kabi AG |
How long does FDA review take for CAC?
The median FDA review time for CAC is 101 days, measured across the 195 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 CAC?
openFDA lists 89 recall records against product code CAC. A recall record covers one firm's corrective action and may span many device lots.
Z-0709-2024Open, ClassifiedMaquet Cardiovascular, LLC
Express chest drains are pre-packaged with sterile water syringes which have bene recalled. If the device is not kept in an upright position, the patient may be exposed to infectious material. Subsequent hazards include but are not limited to infection, abscess, sepsis, and death.
Z-0710-2024Open, ClassifiedMaquet Cardiovascular, LLC
Express chest drains are pre-packaged with sterile water syringes which have bene recalled. If the device is not kept in an upright position, the patient may be exposed to infectious material. Subsequent hazards include but are not limited to infection, abscess, sepsis, and death.
Z-0621-2024Open, ClassifiedAtrium Medical Corporation
A sterilization nonconformance prematurely aged the product by 48.3 days, resulting in the expiration date on the label not being accurate. This nonconforming product was inadvertently distributed to customers. Increased risk to patients and healthcare providers using the product after the shortened expiration date of November 17, 2025.
Z-0316-2024Open, ClassifiedAtrium Medical Corporation
Instructions for Use (IFU) for the Atrium Ocean, Oasis, and Express chest drains do not provide sufficient precaution instruction for proper set up of catheter(s) and patient tube connections with single collection chamber chest drains
Z-0317-2024Open, ClassifiedAtrium Medical Corporation
Instructions for Use (IFU) for the Atrium Ocean, Oasis, and Express chest drains do not provide sufficient precaution instruction for proper set up of catheter(s) and patient tube connections with single collection chamber chest drains
Showing the 5 most recently initiated of 89. 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 CAC?
MAUDE holds 309 adverse-event reports naming product code CAC, 75 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 CAC unusual?
Every month with enough history behind it falls inside CAC's own expected range. Nothing here is unusual for this code.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 5 | 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 | |
| 2 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 6 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 7 | Insufficient history | No expected range — too little history | |
| 9 | Insufficient history | No expected range — too little history | |
| 7 | Insufficient history | No expected range — too little history | |
| 11 | Insufficient history | No expected range — too little history | |
| 11 | Insufficient history | No expected range — too little history | |
| 16 | Insufficient history | No expected range — too little history | |
| 14 | Insufficient history | No expected range — too little history | |
| 40 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 15 | 0–32 | Within expected (0–32) | |
| 9 | 0–28 | Within expected (0–28) | |
| 11 | 0–30 | Within expected (0–30) | |
| 10 | 0–30 | Within expected (0–30) | |
| 9 | 0–27 | Within expected (0–27) | |
| 7 | 0–27 | Within expected (0–27) | |
| 9 | 0–41 | Within expected (0–41) | |
| 21 | 0–30 | Within expected (0–30) | |
| 11 | 0–35 | Within expected (0–35) | |
| 8 | 0–34 | Within expected (0–34) | |
| 5 | 0–30 | Within expected (0–30) | |
| 8 | 0–20 | Within expected (0–20) | |
| 10 | 0–22 | Within expected (0–22) | |
| 9 | 0–17 | Within expected (0–17) | |
| 10 | 1–19 | Within expected (1–19) |
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 CAC.
What are the predicate devices in CAC?
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 CAC?
Across the 195 most recent decisions, these applicants filed most often in CAC.
| Applicant | Recent clearances |
|---|---|
| Haemonetics Corp. | 15 |
| Boehringer Laboratories | 12 |
| Deknatel, Inc. | 11 |
| Shiley, Inc. | 11 |
| Atrium Medical Corp. | 9 |
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 CAC 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 |
|---|---|---|
| Haemonetics Corporation | 18 | 2 |
| Atrium Medical Corporation | 10 | 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 CAC
Get an email the morning anything changes in CAC — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
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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.