Medical device manufacturer
Respironics, Inc.
Respironics, Inc. holds 174 FDA 510(k) clearances across 42 product codes. Median elapsed review time is 90 days. openFDA lists 54 recall records naming the company. FDA publishes it under 10 different spellings, all counted here as one company.
Updated · ingest status · JSON
- 510(k) clearances
- 174
- Product codes
- 42
- Median review
- 90 days
- Recall records
- 54
How does FDA spell Respironics, Inc.?
FDA publishes this company under 10 different spellings across its datasets. Every figure on this page counts all of them as one company, which is why the totals here are higher than a search for any single spelling would give you.
| As FDA published it | Dataset | Matched by |
|---|---|---|
| RESPIRONICS INC. | device/registrationlisting | normalised |
| RESPIRONICS, INC. | device/registrationlisting | normalised |
| Respironics | device/recall | normalised |
| Respironics , Ltd. | device/510k | normalised |
| Respironics Inc. (Dba Philips Respironics) | device/510k | normalised |
| Respironics, Inc. | device/recall | normalised |
| Respironics, Inc. | device/registrationlisting | normalised |
| Respironics, Inc. | device/enforcement | normalised |
Showing 8 of 10.
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, because two genuinely different firms with similar names is the error that would corrupt every count on this page.
Which product codes does Respironics, Inc. file in?
42 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| BZD | Ventilator, Non-Continuous (Respirator) | 68 | 112 days | |
| CBK | Ventilator, Continuous, Facility Use | 14 | 127 days | |
| MNS | Ventilator, Continuous, Non-Life-Supporting | 12 | 111 days | |
| MNR | Ventilatory Effort Recorder | 6 | 111 days | |
| MNT | Sv70 Ventilator | 6 | 180 days | |
| BTM | Ventilator, Emergency, Manual (Resuscitator) | 5 | 87 days | |
| BYE | Attachment, Breathing, Positive End Expiratory Pressure | 5 | 78 days | |
| CAW | Generator, Oxygen, Portable | 5 | 102 days | |
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | 4 | 86 days | |
| BYJ | Unit, Liquid-Oxygen, Portable | 3 | 88 days | |
| CBH | Device, Fixation, Tracheal Tube | 3 | 36 days | |
| GWK | Conditioner, Signal, Physiological | 3 | 59 days | |
| OLZ | Automatic Event Detection Software For Polysomnograph With Electroencephalograph | 3 | 90 days | |
| BYT | Ventilator, External Body, Negative Pressure, Adult (Cuirass) | 2 | 80 days | |
| BZE | Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer | 2 | 110 days | |
| CAE | Airway, Oropharyngeal, Anesthesiology | 2 | 22 days | |
| CAP | Monitor, Airway Pressure (Includes Gauge And/Or Alarm) | 2 | 88 days | |
| KMA | Irrigator, Powered Nasal | 2 | 57 days | |
| LRK | Device, Anti-Snoring | 2 | 58 days | |
| MQM | Bilirubin (Total And Unbound) In The Neonate Test System | 2 | 70 days | |
| NPF | Monitor, Apnea, Home Use | 2 | 84 days | |
| BSJ | Mask, Gas, Anesthetic | 1 | 62 days | |
| BSK | Cuff, Tracheal Tube, Inflatable | 1 | 62 days | |
| BSY | Catheters, Suction, Tracheobronchial | 1 | 62 days | |
| BTK | Strap, Head, Gas Mask | 1 | 16 days |
Showing the 25 they file in most, of 42.
Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Has Respironics, Inc. had a recall?
openFDA lists 54 recall records naming this company across its whole history. A recall record covers one firm's corrective action and may span many device lots.
Z-2024-2012Class ITerminatedCBK
The specified Trilogy units are being recalled because of the potential for a faulty component in the power supply.
Z-0296-2012TerminatedCBK
Trilogy 100, 200 and 202 units are being recalled due to low impeller press-force used during the manufacturing process. If the press force were low enough, theoretically the impeller could move up the shaft and come into contact with the inside of the blower housing/impeller enclosure. This may impact therapy.
Z-1896-2010TerminatedCBK
It is possible that the battery could electrically short, resulting in a potential for fire or a thermal event.
Z-1411-2009TerminatedFLS
Audible alarm failure.
Z-1260-2009TerminatedBZD
Malfunction of the J3 connection between the Heater Plate Main printed circuit assembly (PCA) and the heater plate may have an intermittent connection which may lead to excessive heat build-up on the humidifier PCA.
Showing the 5 most recently initiated of 54.
Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.
Source: openFDA device/recall · retrieved
What has Respironics, Inc. cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K243394 | AF531 Oro-Nasal SE Face Mask | CBK | 60 | |
| K231313 | Therapy Mask 3100 NC/SP | BZD | 84 | |
| K210844 | DreamWear Silicone Pillows Mask | BZD | 155 | |
| K210386 | Magneto Nasal Mask | BZD | 153 | |
| K202142 | Sleepware G3 | OLZ | 90 | |
| K201439 | Ventilator, Non-continuous (Respirator) | BZD | 116 | |
| K200480 | DreamStation 2 System, DreamStation 2 Advanced System | BZD | 134 | |
| K183625 | SomnaPatch | MNR | 296 | |
| K183226 | Care Orchestrator Essence | BZD | 332 | |
| K181170 | Trilogy Evo Universal | CBK | 442 |
Source: openFDA device/510k · retrieved
Where is Respironics, Inc. registered?
FDA lists 4 registered establishments for this company in US.
Registration means the firm has told FDA it makes or distributes devices from that site. It is not a clearance, an approval or an endorsement.
Watch what Respironics, Inc. files next
Get an email when this company clears a new device, or when anything is recalled in a product code you follow.
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.