Medical device manufacturer
Puritan Bennett Corporation
Puritan Bennett Corporation holds 114 FDA 510(k) clearances across 32 product codes. Median elapsed review time is 76 days. openFDA lists 2 recall records naming the company. FDA publishes it under 4 different spellings, all counted here as one company.
Updated · ingest status · JSON
- 510(k) clearances
- 114
- Product codes
- 32
- Median review
- 76 days
- Recall records
- 2
How does FDA spell Puritan Bennett Corporation?
FDA publishes this company under 4 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 |
|---|---|---|
| Puritan Bennett | device/recall | normalised |
| Puritan Bennett Corp. | device/510k | normalised |
| Puritan Bennett Corporation | device/recall | normalised |
| Puritan-Bennett | device/510k | normalised |
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 Puritan Bennett Corporation file in?
32 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| CBK | Ventilator, Continuous, Facility Use | 34 | 90 days | |
| BTM | Ventilator, Emergency, Manual (Resuscitator) | 13 | 28 days | |
| BZD | Ventilator, Non-Continuous (Respirator) | 8 | 117 days | |
| BYJ | Unit, Liquid-Oxygen, Portable | 7 | 50 days | |
| BYE | Attachment, Breathing, Positive End Expiratory Pressure | 6 | 21 days | |
| BZG | Spirometer, Diagnostic | 5 | 78 days | |
| CAW | Generator, Oxygen, Portable | 4 | 76 days | |
| CAN | Regulator, Pressure, Gas Cylinder | 3 | 77 days | |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 3 | 28 days | |
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | 2 | 22 days | |
| CBZ | Analyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling | 2 | 70 days | |
| DQA | Oximeter | 2 | 42 days | |
| NFB | Conserver, Oxygen | 2 | 23 days | |
| BSZ | Gas-Machine, Anesthesia | 1 | 60 days | |
| BWF | Spirometer, Therapeutic (Incentive) | 1 | 12 days | |
| BXN | Stimulator, Nerve, Battery-Powered | 1 | 15 days | |
| BYG | Mask, Oxygen | 1 | 55 days | |
| BYT | Ventilator, External Body, Negative Pressure, Adult (Cuirass) | 1 | 81 days | |
| BZC | Calculator, Pulmonary Function Data | 1 | 29 days | |
| BZL | Computer, Oxygen-Uptake | 1 | 721 days | |
| BZM | Calculator, Pulmonary Function Interpretor (Diagnostic) | 1 | 260 days | |
| BZO | Set, Tubing And Support, Ventilator (W Harness) | 1 | 36 days | |
| CAF | Nebulizer (Direct Patient Interface) | 1 | 233 days | |
| CAH | Filter, Bacterial, Breathing-Circuit | 1 | 48 days | |
| CAX | Flowmeter, Tube, Thorpe, Back-Pressure Compensated | 1 | 26 days |
Showing the 25 they file in most, of 32.
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 Puritan Bennett Corporation had a recall?
openFDA lists 2 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-0444-2007TerminatedMNT
Directions for Use-Puritan Bennett has determined that a service interval should be defined for the device. The firm has also determined that an exhalation filter should be employed when the device is in use.
Z-1085-05TerminatedCBK
Manufacturing defect at contract manufacturer, employee error, poor training, improper inspection.
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 Puritan Bennett Corporation cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K063650 | VENTILATOR WITH RESPIRATORY MECHANICS, MODEL 840 | CBK | 69 | |
| K053388 | MODEL 840 VENTILATOR WITH PROPORTIONAL ASSIST VENTILATION PLUS SOFTWARE OPTION | CBK | 120 | |
| K023225 | PURITAN BENNETT DATAFLOW DATA MANAGEMENT SOFTWARE | BZG | 82 | |
| K022103 | PURITAN-BENNETT 700 RENAISSANCE II SPIROMETRY SYSTEM | BZG | 91 | |
| K021573 | PURITAN-BENNETT 840 VENTILATIOR SYSTEM WITH VOLUME VENTILATION PLUS OPTION | CBK | 91 | |
| K001646 | PURITAN-BENNETT 840 VENTILATOR SYSTEM WITH NEOMODE OPTION | CBK | 143 | |
| K002001 | BREEZE SLEEPGEAR WITH DREAMSEAL | BZD | 68 | |
| K993071 | PURITAN-BENNETT VENTILATOR SYSTEM WITH ET/TRACHEOSTOMY TUBE COMPENSATION, TC, OPTION, MODEL 840 | CBK | 71 | |
| K993220 | PURITAN-BENNETT HELIOS PORTABLE LIQUID OXYGEN SYSTEM | BYJ | 25 | |
| K993088 | PURITAN-BENNETT AERIS 590 OXYGEN CONCENTRATOR WITH OCI | CAW | 22 |
Source: openFDA device/510k · retrieved
Watch what Puritan Bennett Corporation files next
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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.