FDA product code · Anesthesiology
CAHFilter, Bacterial, Breathing-Circuit
Product code CAH covers Filter, Bacterial, Breathing-Circuit, a Class II device regulated under 21 CFR 868.5260. FDA has cleared 202 devices in this code, 2 of them in the last 12 months. Median review time across the 202 most recent decisions is 87 days. openFDA lists 28 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 868.5260
- Review panel
- Anesthesiology
- Clearances
- 202
What is happening in CAH right now?
CAH (Filter, Bacterial, Breathing-Circuit) has three findings, most consequential first. 1 recall opened in the last 12 months and not yet terminated (Class I) (Z-0449-2026). 1 first-time filer in the last 12 months, Ambu A/S (K251583). The code is crowded, scoring 69 of 100 — 119 companies hold a clearance here and 2 arrived in the last 12 months (CAH:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| Recall | Class I recall | Z-0449-2026 |
| New entrant | Worth knowing | K251583 |
| Crowding | Context | CAH: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 CAH?
FDA has cleared 202 devices under product code CAH since the 510(k) programme began in 1976, 2 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252643 | Iso-Gard Filter Straight; Humid-Vent Filter Compact Angled | Teleflex Medical Sdn. Bhd. | |
| K251583 | Ambu® Virobac II® Exhalation Filter | Ambu A/S | |
| K241339 | Besmed Bacterial Filter and HMEF | Besmed Health Business Corp | |
| K222917 | Breathing circuit bacterial/viral filter | Shaoxing Haitech Medical Products Co., Ltd. | |
| K230483 | Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15) | Passy-Muir, Inc. | |
| K223258 | TNI Clear-Guard 3 angled breathing filter (1545020) | Intersurgical , Ltd. | |
| K221472 | Filter and HME/Filter | Ningbo Huakun Medical Equipment Co., Ltd. | |
| K221836 | Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus | Drägerwerk AG & Co. KGaA | |
| K221250 | EasyOne Filter | Ndd Medizintechnik AG | |
| K210352 | GGM Breathing Circuit Bacterial Filter | Great Group Medical Co, Ltd. |
How long does FDA review take for CAH?
The median FDA review time for CAH is 87 days, measured across the 202 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 CAH?
openFDA lists 28 recall records against product code CAH. A recall record covers one firm's corrective action and may span many device lots.
Z-0449-2026Open, ClassifiedMedline Industries, LP
Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic agents, which may result in serious injury or death. Volatile anesthetics may also escape into the operating room environment.
Z-2158-2025Open, ClassifiedDraeger, Inc.
Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.
Z-2159-2025Open, ClassifiedDraeger, Inc.
Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.
Z-2160-2025Open, ClassifiedDraeger, Inc.
Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.
Z-2161-2025Open, ClassifiedDraeger, Inc.
Reports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters.
Showing the 5 most recently initiated of 28. 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 CAH?
MAUDE holds 183 adverse-event reports naming product code CAH, 46 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 CAH unusual?
2 months sit above CAH's own expected range: 1 April 2025, 1 May 2025.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 2 | Insufficient history | No expected range — too little history | |
| 4 | 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 | |
| 6 | 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 | |
| 3 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history | |
| 6 | Insufficient history | No expected range — too little history | |
| 4 | 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 | |
| 5 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 4 | 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 | |
| 4 | Insufficient history | No expected range — too little history | |
| 5 | Insufficient history | No expected range — too little history | |
| 5 | 1–7 | Within expected (1–7) | |
| 5 | 1–6 | Within expected (1–6) | |
| 6 | 2–7 | Within expected (2–7) | |
| 10 | 2–8 | Above expected (2–8) | |
| 11 | 2–10 | Above expected (2–10) | |
| 5 | 2–14 | Within expected (2–14) | |
| 9 | 2–20 | Within expected (2–20) | |
| 3 | 2–14 | Within expected (2–14) | |
| 5 | 0–13 | Within expected (0–13) | |
| 7 | 0–13 | Within expected (0–13) | |
| 3 | 0–11 | Within expected (0–11) | |
| 10 | 0–12 | Within expected (0–12) | |
| 9 | 0–15 | Within expected (0–15) | |
| 5 | 1–13 | Within expected (1–13) | |
| 4 | 0–14 | Within expected (0–14) |
20 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 CAH.
Who has entered CAH in the last year?
One company filed in CAH for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| Ambu A/S | K251583 |
"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 CAH?
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 CAH?
Across the 202 most recent decisions, these applicants filed most often in CAH.
| Applicant | Recent clearances |
|---|---|
| Intersurgical, Inc. | 9 |
| Medipart Jerry Alexander | 8 |
| Porous Media Corp. | 6 |
| King Systems Corp. | 5 |
| Mallinckrodt Medical | 5 |
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 CAH 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 |
|---|---|---|
| Intersurgical Inc | 11 | 3 |
| Datex-Ohmeda, Inc. | 5 | 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 CAH
Get an email the morning anything changes in CAH — 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.