FDA product code · Anesthesiology
CBKVentilator, Continuous, Facility Use
Product code CBK covers Ventilator, Continuous, Facility Use, a Class II device regulated under 21 CFR 868.5895. FDA has cleared 505 devices in this code, 6 of them in the last 12 months. Median review time across the 505 most recent decisions is 127 days. openFDA lists 322 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 868.5895
- Review panel
- Anesthesiology
- Clearances
- 505
What is happening in CBK right now?
CBK (Ventilator, Continuous, Facility Use) has three findings, most consequential first. 5 recalls opened in the last 12 months and not yet terminated (Class I, Class II) (Z-2735-2026, Z-2525-2026, Z-1614-2026, Z-1615-2026, Z-1616-2026). 2 first-time filers in the last 12 months, Iconic Solutions by Murcia, SL and Oconnell Regulatory Consultants, Inc (K252663, K232365). The code is crowded, scoring 81 of 100 — 133 companies hold a clearance here and 6 arrived in the last 12 months (CBK:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| Recall | Class I recall | Z-2735-2026, Z-2525-2026, Z-1614-2026, Z-1615-2026, Z-1616-2026 |
| New entrant | Worth knowing | K252663, K232365 |
| Crowding | Context | CBK: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 CBK?
FDA has cleared 505 devices under product code CBK since the 510(k) programme began in 1976, 6 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253647 | Evita (V800); Evita (V600) | Draegerwerk AG & CO Kgaa | |
| K252663 | Inbentus Versatile | Iconic Solutions by Murcia, SL | |
| K251888 | VPAP Pediatric Face Mask | Hsiner Co., Ltd. | |
| K232365 | Vivo 45 LS | Oconnell Regulatory Consultants, Inc. | |
| K252173 | F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits Size A (ONIV117A); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits Size B (ONIV117B); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits Size C (ONIV117C); F&P OptiNIV ONIV117-F Hospital Vented Full Face Mask with optional Expiratory Filter Compatible with Single-limb Circuits - Size A (ONIV117A-F); F&P OptiNIV ONIV117-F Hospital Vented Full | Fisher & Paykel Healthcare, Ltd. | |
| K243767 | SV600, SV800 Ventilator | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | |
| K251133 | AVEA disposable expiratory filter/water trap (11790) | Telesair, Inc. | |
| K243394 | AF531 Oro-Nasal SE Face Mask | Respironics, Inc. | |
| K233486 | 731 Series Ventilator | ZOLL Medical Corporation | |
| K223120 | Ventoux VC2; Ventoux VC3 | Flight Medical Innovations , Ltd. |
How long does FDA review take for CBK?
The median FDA review time for CBK is 127 days, measured across the 505 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 CBK?
openFDA lists 322 recall records against product code CBK. A recall record covers one firm's corrective action and may span many device lots.
Z-2735-2026Open, ClassifiedResmed Corporation
Due to a Supercapacitor electrolyte leakage on Printed Circuit Board Assembly (PCBA) may damage the charger chip, causing fail-safe state and interruption of ventilation therapy.
Z-2525-2026Open, ClassifiedVentec Life Systems, Inc.
Respiratory system intended to provide continuous/intermittent ventilator support, may have a damaged back-up battery supporting backup alarm function, which may result in the backup alarm not activating during loss of primary power and absence/depletion of backup power sources, which may result in delayed caregiver awareness of a hazardous condition.
Z-1614-2026Open, ClassifiedPhilips Respironics, Inc.
Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by the patient.
Z-1615-2026Open, ClassifiedPhilips Respironics, Inc.
Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by the patient.
Z-1616-2026Open, ClassifiedPhilips Respironics, Inc.
Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by the patient.
Showing the 5 most recently initiated of 322. 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 CBK?
MAUDE holds 55,735 adverse-event reports naming product code CBK, 8,186 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 CBK unusual?
Every month with enough history behind it falls inside CBK's own expected range. Nothing here is unusual for this code.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 1,236 | Insufficient history | No expected range — too little history | |
| 1,886 | Insufficient history | No expected range — too little history | |
| 2,117 | Insufficient history | No expected range — too little history | |
| 1,656 | Insufficient history | No expected range — too little history | |
| 1,527 | Insufficient history | No expected range — too little history | |
| 1,558 | Insufficient history | No expected range — too little history | |
| 1,673 | Insufficient history | No expected range — too little history | |
| 3,129 | Insufficient history | No expected range — too little history | |
| 2,834 | Insufficient history | No expected range — too little history | |
| 2,185 | Insufficient history | No expected range — too little history | |
| 2,138 | Insufficient history | No expected range — too little history | |
| 2,418 | Insufficient history | No expected range — too little history | |
| 1,392 | Insufficient history | No expected range — too little history | |
| 1,490 | Insufficient history | No expected range — too little history | |
| 1,337 | Insufficient history | No expected range — too little history | |
| 1,623 | Insufficient history | No expected range — too little history | |
| 1,394 | Insufficient history | No expected range — too little history | |
| 1,465 | Insufficient history | No expected range — too little history | |
| 1,892 | Insufficient history | No expected range — too little history | |
| 1,580 | Insufficient history | No expected range — too little history | |
| 1,422 | Insufficient history | No expected range — too little history | |
| 1,305 | 640–2,214 | Within expected (640–2,214) | |
| 1,089 | 571–1,851 | Within expected (571–1,851) | |
| 1,233 | 680–1,958 | Within expected (680–1,958) | |
| 1,454 | 1,094–1,550 | Within expected (1,094–1,550) | |
| 1,244 | 1,061–1,493 | Within expected (1,061–1,493) | |
| 1,032 | 1,088–1,539 | Below expected (1,088–1,539) | |
| 1,109 | 1,488–2,378 | Below expected (1,488–2,378) | |
| 861 | 747–1,795 | Within expected (747–1,795) | |
| 1,053 | 540–1,881 | Within expected (540–1,881) | |
| 1,115 | 453–1,867 | Within expected (453–1,867) | |
| 892 | 450–1,611 | Within expected (450–1,611) | |
| 1,230 | 466–1,719 | Within expected (466–1,719) | |
| 923 | 605–2,013 | Within expected (605–2,013) | |
| 977 | 386–1,631 | Within expected (386–1,631) | |
| 1,408 | 433–1,758 | Within expected (433–1,758) |
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 CBK.
Who has entered CBK in the last year?
2 companies filed in CBK for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| Iconic Solutions by Murcia, SL | K252663 | |
| Oconnell Regulatory Consultants, Inc. | K232365 |
"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 CBK?
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 CBK?
Across the 505 most recent decisions, these applicants filed most often in CBK.
| Applicant | Recent clearances |
|---|---|
| Puritan Bennett Corp. | 33 |
| Hamilton Medical AG | 25 |
| Bird Products Corp. | 21 |
| Newport Medical Instruments, Inc. | 17 |
| Siemens Elema AB | 15 |
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 CBK 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 |
|---|---|---|
| Hamilton Medical AG | 35 | 2 |
| Puritan Bennett Corporation | 34 | 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 CBK
Get an email the morning anything changes in CBK — 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.