Puritan Bennett Corp.: FDA filings under this applicant name
FDA lists 114 510(k) clearances under 2 spellings of the applicant name “Puritan Bennett Corp.” (first 1976, latest 2007), across 33 product codes in 3 review panels. Median 510(k) review time under this name: 76 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Medtronic, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| CBK | Ventilator, Continuous, Facility Use | 34 | 34 |
| BTM | Ventilator, Emergency, Manual (Resuscitator) | 13 | 13 |
| BZD | Ventilator, Non-Continuous (Respirator) | 8 | 8 |
| BYJ | Unit, Liquid-Oxygen, Portable | 7 | 7 |
| BYE | Attachment, Breathing, Positive End Expiratory Pressure | 6 | 6 |
| BZG | Spirometer, Diagnostic | 5 | 5 |
| CAW | Generator, Oxygen, Portable | 4 | 4 |
| CAN | Regulator, Pressure, Gas Cylinder | 3 | 3 |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 3 | 3 |
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | 2 | 2 |
Plus 23 more product codes.
Review panels
- Anesthesiology (105)
- Cardiovascular (3)
- General Hospital (2)
Most recent Puritan Bennett Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K063650 | VENTILATOR WITH RESPIRATORY MECHANICS, MODEL 840 | CBK | 2007-02-15 | 69 |
| K053388 | MODEL 840 VENTILATOR WITH PROPORTIONAL ASSIST VENTILATION PLUS SOFTWARE OPTION | CBK | 2006-04-04 | 120 |
| K023225 | PURITAN BENNETT DATAFLOW DATA MANAGEMENT SOFTWARE | BZG | 2002-12-18 | 82 |
| K022103 | PURITAN-BENNETT 700 RENAISSANCE II SPIROMETRY SYSTEM | BZG | 2002-09-27 | 91 |
| K021573 | PURITAN-BENNETT 840 VENTILATIOR SYSTEM WITH VOLUME VENTILATION PLUS OPTION | CBK | 2002-08-13 | 91 |
| K001646 | PURITAN-BENNETT 840 VENTILATOR SYSTEM WITH NEOMODE OPTION | CBK | 2000-10-20 | 143 |
| K002001 | BREEZE SLEEPGEAR WITH DREAMSEAL | BZD | 2000-09-06 | 68 |
| K993071 | PURITAN-BENNETT VENTILATOR SYSTEM WITH ET/TRACHEOSTOMY TUBE COMPENSATION, TC, OPTION, MODEL 840 | CBK | 1999-11-24 | 71 |
| K993220 | PURITAN-BENNETT HELIOS PORTABLE LIQUID OXYGEN SYSTEM | BYJ | 1999-10-22 | 25 |
| K993088 | PURITAN-BENNETT AERIS 590 OXYGEN CONCENTRATOR WITH OCI | CAW | 1999-10-08 | 22 |
104 earlier clearances. See the full list in Caduvo.
Recalls
2 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2006-08-31.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Puritan Bennett Corp. (a text match, not an official crosswalk):
FDA spellings included
FDA records this applicant under 2 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- Puritan Bennett Corp. (110)
- Puritan-Bennett (4)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Puritan Medical Products, LLC (8 510(k)s)
- Puritan-Bennett Ireland, Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Puritan Bennett Corp.?
FDA lists 114 510(k) clearances under 2 spellings of the applicant name “Puritan Bennett Corp.” (first 1976, latest 2007), across 33 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Puritan Bennett Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Puritan Bennett Corp. is 76 days.
Which FDA product codes appear under Puritan Bennett Corp.?
The most frequent FDA product codes under this applicant name are CBK (Ventilator, Continuous, Facility Use, 34); BTM (Ventilator, Emergency, Manual (Resuscitator), 13); BZD (Ventilator, Non-Continuous (Respirator), 8).
Next steps
- See all 114 Puritan Bennett Corp. clearances with predicates and recalls
- Run predicate analysis for product code CBK, Puritan Bennett Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.