FDA product code · Anesthesiology
BZDVentilator, Non-Continuous (Respirator)
Product code BZD covers Ventilator, Non-Continuous (Respirator), a Class II device regulated under 21 CFR 868.5905. FDA has cleared 461 devices in this code, 10 of them in the last 12 months. Median review time across the 461 most recent decisions is 126 days. openFDA lists 81 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 868.5905
- Review panel
- Anesthesiology
- Clearances
- 461
What is happening in BZD right now?
BZD (Ventilator, Non-Continuous (Respirator)) has three findings, most consequential first. 3 first-time filers in the last 12 months, including Resvent Medical Technology Co., Ltd. and Dcstar, Inc (K253044, K251920, K251770). Clearances are running 60% slower — a median 202 days over the last 12 months against 126 days all-time (elapsed calendar days, not FDA review days) (BZD:review_time:12m). The code is crowded, scoring 85 of 100 — 111 companies hold a clearance here and 10 arrived in the last 12 months (BZD:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| New entrant | Worth knowing | K253044, K251920, K251770 |
| Review time | Context | BZD:review_time:12m |
| Crowding | Context | BZD: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 BZD?
FDA has cleared 461 devices under product code BZD since the 510(k) programme began in 1976, 10 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253044 | RXiBreeze PAP System (RXiBreeze 20C) | Resvent Medical Technology Co., Ltd. | |
| K253553 | Orion | Resmed Corp | |
| K254104 | ResScan Essentials | Resmed Corp | |
| K251920 | Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face Mask | Dcstar, Inc. | |
| K253166 | F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S) | BMC Medical Co., Ltd. | |
| K252338 | MySleepDash | Somnetics International, Inc. (Dba Transcend Inc) | |
| K251847 | Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented Mask | Sleepnet Corporation | |
| K253939 | DeltaWave Nasal Pillow System | RemSleep Holdings, Inc. | |
| K251770 | SleepRes PAP System | Sleepres, Inc. | |
| K251657 | Personalized Therapy Comfort Settings (PTCS) | Resmed Corp |
How long does FDA review take for BZD?
The median FDA review time for BZD is 126 days, measured across the 461 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 BZD?
openFDA lists 81 recall records against product code BZD. A recall record covers one firm's corrective action and may span many device lots.
Z-2227-2025Open, ClassifiedPhilips Respironics, Inc.
Devices may possess a programming error resulting in an incorrect device configuration.
Z-2228-2025Open, ClassifiedPhilips Respironics, Inc.
Devices may possess a programming error resulting in an incorrect device configuration.
Z-2229-2025Open, ClassifiedPhilips Respironics, Inc.
Devices may possess a programming error resulting in an incorrect device configuration.
Z-1351-2024Open, ClassifiedSleepNet Corporation
Update to contraindications and warning language due to CPAP masks containing magnets.
Z-1352-2024Open, ClassifiedSleepNet Corporation
Update to contraindications and warning language due to CPAP masks containing magnets.
Showing the 5 most recently initiated of 81. 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 BZD?
MAUDE holds 158,096 adverse-event reports naming product code BZD, 27,692 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 BZD unusual?
2 months sit above BZD's own expected range: 1 January 2025, 1 February 2025.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 2,828 | Insufficient history | No expected range — too little history | |
| 1,929 | Insufficient history | No expected range — too little history | |
| 1,222 | Insufficient history | No expected range — too little history | |
| 1,181 | Insufficient history | No expected range — too little history | |
| 1,642 | Insufficient history | No expected range — too little history | |
| 1,363 | Insufficient history | No expected range — too little history | |
| 1,702 | Insufficient history | No expected range — too little history | |
| 2,472 | Insufficient history | No expected range — too little history | |
| 2,506 | Insufficient history | No expected range — too little history | |
| 4,122 | Insufficient history | No expected range — too little history | |
| 4,460 | Insufficient history | No expected range — too little history | |
| 4,603 | Insufficient history | No expected range — too little history | |
| 6,631 | Insufficient history | No expected range — too little history | |
| 8,326 | Insufficient history | No expected range — too little history | |
| 6,705 | Insufficient history | No expected range — too little history | |
| 6,469 | Insufficient history | No expected range — too little history | |
| 6,116 | Insufficient history | No expected range — too little history | |
| 4,458 | Insufficient history | No expected range — too little history | |
| 7,284 | Insufficient history | No expected range — too little history | |
| 5,273 | Insufficient history | No expected range — too little history | |
| 3,817 | Insufficient history | No expected range — too little history | |
| 9,031 | 2,065–7,546 | Above expected (2,065–7,546) | |
| 12,292 | 2,420–8,170 | Above expected (2,420–8,170) | |
| 13,146 | 2,723–13,831 | Within expected (2,723–13,831) | |
| 4,446 | 3,264–16,924 | Within expected (3,264–16,924) | |
| 1,458 | 1,292–14,491 | Within expected (1,292–14,491) | |
| 1,905 | 0–13,684 | Within expected (0–13,684) | |
| 1,676 | 0–20,166 | Within expected (0–20,166) | |
| 682 | 0–14,487 | Within expected (0–14,487) | |
| 768 | 0–14,671 | Within expected (0–14,671) | |
| 780 | 0–14,289 | Within expected (0–14,289) | |
| 8,236 | 0–12,676 | Within expected (0–12,676) | |
| 635 | 0–16,306 | Within expected (0–16,306) | |
| 2,949 | 0–18,105 | Within expected (0–18,105) | |
| 6,335 | 0–14,847 | Within expected (0–14,847) | |
| 7,583 | 0–14,536 | Within expected (0–14,536) |
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 BZD.
Who has entered BZD in the last year?
3 companies filed in BZD for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| Resvent Medical Technology Co., Ltd. | K253044 | |
| Dcstar, Inc. | K251920 | |
| Sleepres, Inc. | K251770 |
"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 BZD?
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 BZD?
Across the 461 most recent decisions, these applicants filed most often in BZD.
| Applicant | Recent clearances |
|---|---|
| Resmed, Ltd. | 81 |
| Respironics, Inc. | 67 |
| Fisher & Paykel Healthcare, Ltd. | 25 |
| Sleepnet Corporation | 18 |
| Resmed Corp | 14 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
The same makers, after name resolution
3 companies in BZD 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 |
|---|---|---|
| Resmed Corporation | 97 | 3 |
| Respironics, Inc. | 68 | 2 |
| Fisher & Paykel Healthcare, Ltd. | 31 | 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 BZD
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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.