Patient Solutions, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Patient Solutions, Inc.” (first 1989, latest 1997), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 86 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 |
|---|---|---|---|
| FRN | Pump, Infusion | 3 | 3 |
| FPA | Set, Administration, Intravascular | 2 | 2 |
Review panels
- General Hospital (5)
Most recent Patient Solutions, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K964384 | MODEL D-290P ADMINISTRATION SET | FPA | 1997-01-27 | 84 |
| K961263 | MODEL 1200 ABMULATORY INFUSION PUMP | FRN | 1996-08-23 | 143 |
| K954841 | MODEL D-285N ADMINISTRATION SET | FPA | 1995-12-11 | 49 |
| K953270 | MODEL 1100 MEDMATE INFUSION PUMP | FRN | 1995-10-07 | 86 |
| K894028 | AMBULATORY INFUSION SYSTEM AND ACCESSORIES | FRN | 1989-12-22 | 199 |
Recalls
openFDA lists no recalls under a recalling firm named Patient Solutions, 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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Patient Solutions, Inc. (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via FRN)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via FRN)
- E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement (via FRN)
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.
- Patient Pocket, LLC (2 510(k)s)
- Patient Data Systems (1 510(k)s)
- Patient Healthguards Corp. (1 510(k)s)
- Patient Safety Products, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Patient Solutions, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Patient Solutions, Inc.” (first 1989, latest 1997), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Patient Solutions, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Patient Solutions, Inc. is 86 days.
Which FDA product codes appear under Patient Solutions, Inc.?
The most frequent FDA product codes under this applicant name are FRN (Pump, Infusion, 3); FPA (Set, Administration, Intravascular, 2).
Next steps
- See all 5 Patient Solutions, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FRN, Patient Solutions, 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.