Puritas Health Care, Inc.: FDA filings under this applicant name
FDA lists 24 510(k) clearances under the applicant name “Puritas Health Care, Inc.” (first 1991, latest 1994), across 15 product codes in 5 review panels. Median 510(k) review time under this name: 94 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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 |
|---|---|---|---|
| FPA | Set, Administration, Intravascular | 6 | 6 |
| BSY | Catheters, Suction, Tracheobronchial | 3 | 3 |
| BRZ | Set, Blood Transfusion | 2 | 2 |
| MDA | Elastomer, Silicone, For Scar Management | 2 | 2 |
| BZO | Set, Tubing And Support, Ventilator (W Harness) | 1 | 1 |
| CAT | Cannula, Nasal, Oxygen | 1 | 1 |
| DSS | Clip, Vascular | 1 | 1 |
| DXC | Clamp, Vascular | 1 | 1 |
| EXR | Urinometer, Mechanical | 1 | 1 |
| FMG | Stopcock, I.V. Set | 1 | 1 |
Plus 5 more product codes.
Review panels
- General Hospital (12)
- Anesthesiology (5)
- General and Plastic Surgery (3)
- Cardiovascular (2)
- Gastroenterology and Urology (2)
Most recent Puritas Health Care, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K942339 | SKIN NEUVEAU SCAR TREATMENT | MDA | 1994-11-28 | 196 |
| K941197 | SILK*SKIN SCAR TREATMENT | MDA | 1994-08-11 | 150 |
| K935600 | TRACHEAL SUCTION CATHETER | BSY | 1994-05-10 | 172 |
| K935531 | OP-FLEX SUMP SUCTION SET WITH DIFFUSER TIP | GBX | 1994-05-05 | 170 |
| K940074 | Y-TYPE BLOOD ADMINISTRATION SET | BRZ | 1994-04-21 | 105 |
| K940055 | MULTISET | BRZ | 1994-04-15 | 100 |
| K940054 | MEASURED VOLUME SOLUTION ADMINISTRATION SET | FPA | 1994-04-15 | 100 |
| K935583 | SUCTION SET, TRACHAEL | BSY | 1994-04-11 | 144 |
| K940070 | STOPCOCK INTRAVENOUS THERAPY | FMG | 1994-04-04 | 88 |
| K940056 | WINGED INFUSION SET A-PORT VASCULAR ACCESS SYSTEM | FPA | 1994-04-04 | 89 |
14 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Puritas Health Care, Inc..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Puritas Health Care, Inc.?
FDA lists 24 510(k) clearances under the applicant name “Puritas Health Care, Inc.” (first 1991, latest 1994), across 15 product codes in 5 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 Puritas Health Care, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Puritas Health Care, Inc. is 94 days.
Which FDA product codes appear under Puritas Health Care, Inc.?
The most frequent FDA product codes under this applicant name are FPA (Set, Administration, Intravascular, 6); BSY (Catheters, Suction, Tracheobronchial, 3); BRZ (Set, Blood Transfusion, 2).
Next steps
- See all 24 Puritas Health Care, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FPA, Puritas Health Care, Inc.'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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.