Pharma Systems, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Pharma Systems, Inc.” (first 1990, latest 1990), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 121 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 |
|---|---|---|---|
| BYD | Condenser, Heat And Moisture (Artificial Nose) | 3 | 3 |
| BZO | Set, Tubing And Support, Ventilator (W Harness) | 1 | 1 |
| CAH | Filter, Bacterial, Breathing-Circuit | 1 | 1 |
Review panels
- Anesthesiology (4)
- General Hospital (1)
Most recent Pharma Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K903057 | FREEVENT (TM) | BYD | 1990-11-20 | 132 |
| K903058 | BACT-HME (TM) | BYD | 1990-11-09 | 121 |
| K903055 | EXTENDED LIFE CIRCUITS | BZO | 1990-11-09 | 121 |
| K903056 | BACTTRAP | CAH | 1990-11-05 | 117 |
| K903054 | HME-10 (TM) | BYD | 1990-10-31 | 112 |
Recalls
openFDA lists no recalls under a recalling firm named Pharma Systems, 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.
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.
- Pharma-Plast USA, Inc. (9 510(k)s)
- Pharma-Medica of Scandinavia, Ltd. (2 510(k)s)
- Pharma-Plast Intl. A/S (2 510(k)s)
- Pharma-Filter, Inc. (1 510(k)s)
- Pharma-Pen, Inc. (1 510(k)s)
- Pharma-Plast, Ltd. (1 510(k)s)
- Pharma System AB (1 510(k)s)
- Pharma Systems AB (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Pharma Systems, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Pharma Systems, Inc.” (first 1990, latest 1990), across 3 product codes in 2 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 Pharma Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Pharma Systems, Inc. is 121 days.
Which FDA product codes appear under Pharma Systems, Inc.?
The most frequent FDA product codes under this applicant name are BYD (Condenser, Heat And Moisture (Artificial Nose), 3); BZO (Set, Tubing And Support, Ventilator (W Harness), 1); CAH (Filter, Bacterial, Breathing-Circuit, 1).
Next steps
- See all 5 Pharma Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code BYD, Pharma Systems, 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 (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.