FDA product code · Anesthesiology
CAFNebulizer (Direct Patient Interface)
Product code CAF covers Nebulizer (Direct Patient Interface), a Class II device regulated under 21 CFR 868.5630. FDA has cleared 508 devices in this code, 4 of them in the last 12 months. Median review time across the 508 most recent decisions is 123 days. openFDA lists 36 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 868.5630
- Review panel
- Anesthesiology
- Clearances
- 508
What is happening in CAF right now?
CAF (Nebulizer (Direct Patient Interface)) has two findings, most consequential first. 2 first-time filers in the last 12 months, FindAir Sp. z o.o. and Shenzhen Jermei Medical Device Technology Co., Ltd (K260270, K244035). The code is crowded, scoring 83 of 100 — 244 companies hold a clearance here and 4 arrived in the last 12 months (CAF:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| New entrant | Worth knowing | K260270, K244035 |
| Crowding | Context | CAF: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 CAF?
FDA has cleared 508 devices under product code CAF 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 |
|---|---|---|---|
| K260270 | FindAir ONE for pMDI (FAO-MDI-V12-GRE-001) | FindAir Sp. z o.o. | |
| K251572 | eRapid with eTrack System | Pari Respiratory Equipment, Inc. | |
| K251659 | Mesh Nebulizer (H6) | Qingdao Future Medical Technology Co., Ltd. | |
| K244035 | Portable mesh nebulizer (JM821) | Shenzhen Jermei Medical Device Technology Co., Ltd. | |
| K243468 | Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101); Compressor Nebulizer (NB-1102); Compressor Nebulizer (NB-1103) | Joytech Healthcare Co. , Ltd. | |
| K250022 | HeroTracker Sense | Voluntis | |
| K250583 | AdheResp Smart Breath-actuated Mesh Nebulizer | Hcmed Innovations Co., Ltd. | |
| K242354 | AllNEB | Enchant Tek Co. , Ltd. | |
| K233553 | MiniSpacer® 1024, 1025, 1543 and 1024A, 1025A, 1543A Dual Spray MDI Adapter | Thayer Medical Corporation | |
| K232507 | Aerogen®Solo Nebulizer System | Aerogen, Ltd. |
How long does FDA review take for CAF?
The median FDA review time for CAF is 123 days, measured across the 508 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 CAF?
openFDA lists 36 recall records against product code CAF. A recall record covers one firm's corrective action and may span many device lots.
Z-2514-2023Open, ClassifiedMEDLINE INDUSTRIES, LP - Northfield
Product dispositioned for scrap for sterility failure investigation that was inadvertently shipped to customers.
Z-1516-2021TerminatedSmiths Medical ASD, Inc.
The firm became aware via complaints that one lot of ACE MDI Spacers with Small Masks and one lot of Palm Cups (Large) may have incorrect shipping box labels.
Z-1058-2019TerminatedSANRAI INTERNATIONAL LLC
The product was designed for 120V usage and is being used in South Africa with 220V. There is a potential for the device to overheat and the mouthpiece can pop off.
Z-0710-2019TerminatedMedex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
Z-0711-2019TerminatedMedex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
Showing the 5 most recently initiated of 36. 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 CAF?
MAUDE holds 408 adverse-event reports naming product code CAF, 136 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 CAF unusual?
One month sits above CAF's own expected range: 1 October 2025.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 5 | Insufficient history | No expected range — too little history | |
| 12 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history | |
| 11 | Insufficient history | No expected range — too little history | |
| 10 | Insufficient history | No expected range — too little history | |
| 7 | Insufficient history | No expected range — too little history | |
| 15 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history | |
| 9 | Insufficient history | No expected range — too little history | |
| 3 | 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 | |
| 2 | Insufficient history | No expected range — too little history | |
| 8 | 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 | |
| 4 | Insufficient history | No expected range — too little history | |
| 25 | Insufficient history | No expected range — too little history | |
| 14 | Insufficient history | No expected range — too little history | |
| 12 | Insufficient history | No expected range — too little history | |
| 16 | 0–22 | Within expected (0–22) | |
| 12 | 0–21 | Within expected (0–21) | |
| 14 | 1–24 | Within expected (1–24) | |
| 20 | 1–26 | Within expected (1–26) | |
| 11 | 2–27 | Within expected (2–27) | |
| 11 | 2–26 | Within expected (2–26) | |
| 9 | 2–39 | Within expected (2–39) | |
| 7 | 0–26 | Within expected (0–26) | |
| 21 | 0–25 | Within expected (0–25) | |
| 44 | 3–26 | Above expected (3–26) | |
| 14 | 4–38 | Within expected (4–38) | |
| 9 | 2–40 | Within expected (2–40) | |
| 14 | 0–43 | Within expected (0–43) | |
| 12 | 0–35 | Within expected (0–35) | |
| 15 | 0–37 | Within expected (0–37) |
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 CAF.
Who has entered CAF in the last year?
2 companies filed in CAF for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| FindAir Sp. z o.o. | K260270 | |
| Shenzhen Jermei Medical Device Technology Co., Ltd. | K244035 |
"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 CAF?
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 CAF?
Across the 508 most recent decisions, these applicants filed most often in CAF.
| Applicant | Recent clearances |
|---|---|
| Airlife, Inc. | 16 |
| Vortran Medical Technology 1, Inc. | 12 |
| Adherium (Nz), Ltd. | 10 |
| Salter Labs | 9 |
| Pari Innovative Manufacturers, Inc. | 8 |
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 CAF 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 |
|---|---|---|
| Reciprocal Labs Corporation | 10 | 2 |
| Aerogen Ltd. | 9 | 3 |
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 CAF
Get an email the morning anything changes in CAF — 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.